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Calibration Technician
Decatur, Illinois
Calibration Technician
Decatur, Illinois
POSITION TITLE:
Director of Finance
DEPARTMENT:
Engineering
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Head of Engineering
POSITION TITLE:
Director of Finance
EXPERIENCE:
4 Years
DEPARTMENT:
Engineering
REPORTS TO:
Head of Engineering
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Responsible for maintenance testing and repairing a variety of instrumentation and equipment. Ensure instruments, gauges, and testing devices are calibrated correctly to provide accurate readings and measurements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ability to install, troubleshoot, and calibrate all types of instruments or control systems in any Rising environment.
- Maintain calibration records and enter calibration data using software such as Calibration Manager.
- Ability to use software such as MS Excel, Word, and other maintenance manager software such as AMMS to purchase items and complete validation documentation.
- Develop SOPs and change controls for new or existing equipment as required.
- Coordinate equipment calibrations for equipment to be calibrated.
- Perform calibrations in a thorough and timely manner in accordance with manufacturer’s recommendations and Rising SOPs.
- Order materials and perform instrument and control system adjustments or repairs necessary.
- to achieve compliance in advance of preventative maintenance and validation completion dates.
- Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays.
- Good organizational skills to maintain a neat, clean, and orderly work environment.
- Possess and maintain competent and quick mathematical ability to perform the above job duties.
- Demonstrate a thorough and timely response to critical facility problems including environmental monitoring, security, and fire alarm parameters.
- Compliance with all OSHA and Rising safety requirements.
- Perform other duties as assigned.
POSITION REQUIREMENTS
Education and Experience
- Basic electrical and electronics trade school training. This would provide only a minimum amount of formal training and a brief exposure to the proper use of tools and techniques.
- Working instrumentation experience may be substituted in lieu of the above if approved by Rising.
Job Prerequisites
- Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines. Able to accept occasional overtime on short notice.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to hear accurately the spoken word with moderate office noise or plant noise;
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to receive instructions and follow work rules and company policies;
- Ability to follow safety and security practices;
- Ability to meet deadlines and effectively deal with office stress;
- Ability to accurately communicate ideas, facts, and technical information; and
- Maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Director – Finance
Decatur, Illinois
Director – Finance
Decatur, Illinois
POSITION TITLE:
Director of Finance
DEPARTMENT:
Finance
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Vice President of FP&A
POSITION TITLE:
Director of Finance
EXPERIENCE:
4 Years
DEPARTMENT:
Finance
REPORTS TO:
Vice President of FP&A
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Responsible for overseeing all financial aspects of the plant’s operations. This includes budgeting, forecasting, financial reporting, cost analysis, inventory management, and ensuring compliance with accounting standards and company policies. Expected to work closely with local VP of Operations and corporate finance team to optimize financial performance and support decision making processes. Will also monitor internal controls to safeguard assets and mitigate financial risks.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop annual standard cost for all inventoriable items by the date TBD.
- Record and verify daily and month-end filled, inspected but not packed, and packed production.
- Prepare monthly, quarterly, and annual Plant Variance Forecasts.
- Publish weekly and/or monthly Plant Variance analysis with commentary.
- Prepare and analyze monthly plant financial spending reports and distribute to local management.
- Work with Engineering & Plant Management to define specific details of proposed capital expenditures.
- Analyze all travel expenses and apply to capital projects as necessary.
- Perform month-end closing duties as determined by Corporate Finance.
- Reconcile Spare Parts listing with general ledger at least quarterly and prepare adjusting entries.
- Assist HR and Payroll by reviewing status codes to ensure proper set up and coding of new employees.
- Develop and implement new procedures to enhance, simplify, and shorten the month-end closing cycle.
- Prepare suggested annual updated unit production by brite-stock and NDC SKUs to be used for new year standard cost by SKU.
- Drive the monthly and quarterly spending and production forecasts along with the annual budget process for the Decatur Operations.
- Serve as a financial resource to the local operations and management team.
- Assist Senior Supply Chain Director with overseeing the Annual Physical Inventory and ensure a solid cycle count method and timing is adhered to. Reconcile monthly perpetual inventory to general ledger.
- Review Decatur Plant accounting requirements annually with Corporate Finance.
- Prepare ad hoc analyses as requested
- Provide response to all audit requests.
POSITION REQUIREMENTS
Education and Experience
- Minimum of a Bachelor’s Degree from a four-year accredited college or university with a major in Accounting, Finance or equivalent. Preference may be given to those with a Master’s Degree or professional certification such as CPA, or CMA.
- 7-10 years experience in Cost Accounting and financial analysis in a fast-paced and growing manufacturing environment.
- Strong analytical skills and proficiency in financial analysis, budgeting, forecasting, and cost management are essential.
- ERP system proficiency, preferably with SAP. Experience in implementing an ERP system is also preferred.
Job Prerequisites
- Advanced Microsoft Excel experience
- Pharmaceutical Industry knowledge preferred
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Excellent leadership skills; ability to lead a team and/or work across departments.
- Strong organizational skills; prioritizes very well; flexible to work in new important initiatives.
- Clearly articulate status of all deliverables.
- Find efficiencies in operations and analyses, while maintaining high level of compliance.
- Strong collaboration, communication, verbal, and written communication skills.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Director – Microbiology
Decatur, Illinois
Director – Microbiology
Decatur, Illinois
POSITION TITLE:
Director of Microbiology
DEPARTMENT:
Microbiology
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Head of Quality
POSITION TITLE:
Director of Microbiology
EXPERIENCE:
4 Years
DEPARTMENT:
Microbiology
REPORTS TO:
Head of Quality
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
The Microbiology Director ensures that all microbiological and environmental monitoring requirements in compliance with cGMP standards, Food and Drug Administration (FDA), European Pharmacopoeia (EP), United States Pharmacopoeia (USP), AMMI, and ISO guidelines. Directs the organization standards as they apply to the department. Directs and oversees the compliance of the department and organization for internal product line and third-party customer line. Interacts with the customer and Agency officials during routine and nonroutine site inspections. Oversees that the staff is trained, troubleshoots microbiological testing problems, development and implementation of departmental procedures are conducted in accordance with SOP’s and methods, and ensure SOP’s and Method’s meet Company and FDA standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Directs the supervision of all microbiological and environmental tests that are performed and reported in compliance with cGMP standards and in a timely manner.
- Overview, conducts, and/or delegates the final review and approval of environmental and microbiological test results including contract labs requirements before the documentation is forwarded to QA Batch Record reviewers.
- Oversee the review of compliance guidelines, industry trends, customer’s projects, validation efforts, and development efforts to ensure Microbiology/Environmental departments meet or exceed the minimum requirements.
- Represent the department and company in all Regulatory and customer audits.
- Oversee the timely completion of projects, CAPAs, and investigations.
- Oversee and assures that the departmental training program meets Company standards.
- Oversee and review responses compliance audits/deficiencies and CAPA plans of areas of responsibility.
- Oversee the coordination of development and validation of microbiological methods.
- Perform employee performance appraisals in a timely
- Oversee and conduct the hiring process of new personnel for the Microbiology and/or Environmental departments (Salary and Hourly).
- Oversee and/or ensure that all laboratory equipment are in compliance with company and regulatory
- Drives in conjunction with other departments and Rising sites the global application of compliance and operation.
Additional Responsibilities
- Directly supervises the Microbiology and Environmental Monitoring Supervisors. Carries out management responsibilities in accordance with the organization’s policies and applicable laws. Planning, assigning, and directing work, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Review of new and revised regulatory and guidance documents and processes/practices to assure continuous improvement and compliance.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with Major in Microbiology or Biology.
- Seven years of experience in a Pharmaceutical Microbiology Laboratory under cGMP guidelines.
- Minimum of three years of management experience preferred.
- Experience should include exposure and understanding in the following areas: FDA, EP, ISO, AMMI regulations, current LISP and Supplement in Microbiological and Environmental requirements, Isolation and identification of Microbial Isolates, Aseptic Techniques, Gowning Techniques, Bioburden Test by MPN, Plate Count, and Membrane Filtration methods, Culture Maintenance and Record Maintenance, BF/Sterility testing, AET, BRT, and Environmental Monitoring Guidelines for Viable and Non-Viable Monitoring.
- An equivalent combination of education and experience may substitute.
Job Prerequisites
- Ability to meet attendance standards. All full-time employees are required to work a minimum 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- This individual must have an understanding of regulatory guidelines and/or compliance documents.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to hear accurately the spoken word with moderate office and plant noise;
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to receive instructions and follow work rules and company policies;
- Ability to follow safety and security practices;
- Ability to meet deadlines and effectively deal with office stress;
- Ability to accurately communicate ideas, facts, and technical information; and
- Maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Project Engineer
Decatur, Illinois
Project Engineer
Decatur, Illinois
POSITION TITLE:
Project Engineer
DEPARTMENT:
Engineering
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Head of Engineering
POSITION TITLE:
Project Engineer
EXPERIENCE:
4 Years
DEPARTMENT:
Engineering
REPORTS TO:
Head of Engineering
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
The Project Engineer develops and implements support and critical equipment utility plans, performs system evaluations, and establishes operational efficiency. This includes project support related to minor facility modifications, equipment installations, and maintenance activities. Strong project management skills and knowledge of facility code requirements are required. Ensures the compliance to facility security and DEA monitoring requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Gathering and analyzing data, blueprints, and reports.
- Determining facility and equipment specifications.
- Maintaining facility, process flow, sampling, etc. drawings to current build.
- Analyzing project costs and preparing budgets.
- Participate in the designing and overseeing the implementation of facility expansion, layout, various systems, and quality controls.
- Evaluating operational systems and facility infrastructure to ascertain and improve operational efficiencies.
- Experience in a senior level position to assist the Manager of Maintenance & Calibration with planning, scheduling, and organizing maintenance activities.
- Perform corrective and preventive maintenance on all facility equipment / systems at Rising facilities. This includes, but is not limited to mechanical, electrical, and HVAC systems. Facility equipment includes air handlers, HEPA filtration, RO water, clean steam, WFI, boilers, compressors, pumps, chillers, and water treatment systems.
- Developing plans and optimizing internal and external resource allocation.
- Work with all departments to support the operations group by enhancing the reliability and performance of equipment at the facilities. This also includes supporting projects during installation and during validation. Keep an open line of communication across departments and managerial lines.
- Planning and coordination infrastructure and equipment maintenance schedules and activities.
- Coordinating and overseeing contractors performing maintenance activities.
- Familiarity and ability to use software systems for Work Orders and Calibration. Ability to identify the appropriate materials and parts to maintain and repair equipment and order the parts using automated methods.
- Ensuring compliance with relevant regulations, building codes and health and safety standards.
- Preparing reports and compliance documentation.
- Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays. This includes timely, accurate, and neat completion of documentation, such as work orders and reports that meet GMP requirements.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with a Major in mechanical, electrical, or industrial engineering.
- A minimum of 3 years of experience as facilities engineer or similar role.
- Experience with AutoCAD, SAP a plus.
- Experience with MS Office.
- Knowledge of building process and construction.
- Knowledge of the building process and construction principles.
- Good verbal and written communication skills.
- Troubleshooting and problem-solving skills.
- Project Management Skills.
Job Prerequisites
- Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times, it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to hear accurately the spoken word with moderate office noise or plant noise.
- Ability to apply deductive reasoning and understand complicated issues.
- Ability to receive instructions and follow work rules and company policies.
- Ability to follow safety and security practices.
- Ability to meet deadlines and effectively deal with office stress.
- Ability to accurately communicate ideas, facts, and technical information.
- Maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Validation Engineer I
Decatur, Illinois
Validation Engineer I
Decatur, Illinois
POSITION TITLE:
Validation Engineer I
DEPARTMENT:
Validation
EXPERIENCE:
4 Years
WORK LOCATION:
Decatur, Illinois
POSITION TITLE:
Validation Engineer I
EXPERIENCE:
4 Years
DEPARTMENT:
Validation
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Responsible for all aspects of the validation process, including: documenting commissioning activities; establishing the process and equipment acceptance criteria; and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes.
Work closely with all departments and be responsible for various projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Schedule and plan equipment and process qualification workload to meet approved schedules.
- Handle multiple projects and work independently.
- Write, execute, and review complex protocols.
- Coordinate validation activities with other departments.
- Operate Thermal Mapping Equipment
- Able to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
- Train other Validation personnel.
- Purchase supplies and equipment for validation activities.
- Administer the site Change Control Program.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with Major Chemistry, Engineering, Microbiology, or a related field.
- Minimum three years experience in the pharmaceutical industry, or equivalent experience.
- Demonstrate experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, dehydrogenation, wet steam and dry heat sterilization, and packaging.
- Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.
Job Prerequisites
- Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Previous experience in the pharmaceutical industry with a manufacturing background.
- Advanced knowledge of cGMP’s and regulatory requirements as they relate to IQ/OQ/PQ/VQ’s.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
- The noise level is usually fairly quiet. Requires normal range of hearing and vision to record, prepare, and communicate appropriate reports. Requires exposure to machines, and occasionally chemicals and solvents.
- Requires moving of loaded carts into and out of equipment. Preparing loads of different weights and sizes to use for validation purposes.
Mental Requirements
- Ability to hear accurately the spoken word with moderate office noise or plant noise;
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to receive instructions and follow work rules and company policies;
- Ability to follow safety and security practices;
- Ability to occasionally work off hours and weekends to meet deadlines;
- Ability to effectively deal with office stress;
- Ability to accurately communicate ideas, facts, and technical information; and
- Ability to maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Validation Manager
Decatur, Illinois
Validation Manager
Decatur, Illinois
POSITION TITLE:
Validation Manager
DEPARTMENT:
Validation
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Head of Engineering
POSITION TITLE:
Validation Manager
EXPERIENCE:
4 Years
DEPARTMENT:
Validation
REPORTS TO:
Head of Engineering
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Provide expertise, guidance, and oversight for the Validation efforts at Rising Facility. Ensure the development and implementation of the Rising Validation Department and the Site Validation Master Plan. Effectively oversee industry “best practices” using resources, such as ISPE and PDA and continuously upgrade the Site’s validation practices and procedures. Manage site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff, and internal departments including outside contractors and vendors, as applicable.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide expertise in the development, execution, and review of validation protocols.
- Develop and maintain a requalification schedule for facilities, equipment and processes based on a risk assessment, current industry “best practices,” and regulatory requirements.
- Able to schedule staff to meet aggressive validation timelines.
- Responsible for the maintenance and implementation of the Rising Validation Master Plan Schedules, including facility, equipment, and process requalifications.
- Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements.
- Able to hire, mentor and train staff, and other resources as needed.
- Able to develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch/manuals, if not readily available.
- Able to handle multiple, complex projects and work independently.
Additional Responsibilities:
- Other duties as assigned.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with Major in Engineering, Chemistry or Microbiology with preference for the Engineering Sciences.
- Or equivalent work experience in the pharmaceutical industry.
- Certified Engineer or CQE is a plus.
- Sterile injectable experience required.
Job Prerequisites
- Must be mentally flexible in dealing with difficult situations.
- Must understand vague and implicit instructions and react favorably in complex situations.
- Excellent communication, writing, and computer skills.
- Ability to meet attendance standards. All full-time employees are required to work a 40 hour week, most of which has to be during “regular” business hours. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Ability to operate and troubleshoot validation monitoring equipment.
- Ability to estimate and maintain project timelines.
- Fully knowledgeable with computerized systems and programs.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to provide instructions and follow up work rules including company policies;
- Ability to ensure safety and security practices;
- Ability to meet deadlines and effectively deal with office stress;
- Ability to accurately communicate ideas, facts, and technical information; and
- Maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Quality Control Chemist
Decatur, Illinois
Quality Control Chemist
Decatur, Illinois
POSITION TITLE:
Quality Control Chemist
DEPARTMENT:
Quality Control
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Supervisor of Quality Control
POSITION TITLE:
Quality Control Chemist
EXPERIENCE:
4 Years
DEPARTMENT:
Quality Control
REPORTS TO:
Supervisor of Quality Control
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Perform the sampling of raw materials, chemical and physical analysis of raw material, bulk formulations, finished products, stability samples, and any non-routine samples.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with a Major in Chemistry or equivalent.
- Prefer, two years of industry experience involving analytical or wet chemistry test procedures in a quality control environment.
- Experience with, Infra-Red (IR), Ultraviolet/Visible Spectroscopy, Particle Size Analysis, KF Titration, and wet chemistry skills are required.
- Familiarity with High Pressure Liquid Chromatography, Gas Chromatography (GC), and HPLC/GC analytical software is preferred, but not required.
- Familiarity with GLP/GMP guidelines.
- Good Communication and writing skills.
- Familiarity with out-of-specification (OOS) investigation.
- Computer literate.
- Experience with USP/EP monographs.
FUNCTIONAL KNOWLEDGE
Knowledge
- Bachelor of Science Degree in Chemistry, Engineering, Microbiology, or a related field and three (3) years’ experience in the pharmaceutical industry, or equivalent experience
COMPANY / INDUSTRY RELATED KNOWLEDGE
Knowledge
- cGMP, DEA, and OSHA compliance
JOB-SPECIFIC COMPETENCIES
- Ability to meet attendance standards.
- At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Working knowledge of MS Word, Excel, Outlook, and Power Point.
- Working knowledge of Adobe Acrobat.
- Excellent conceptualizing, analytical, and problem-solving skills.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Q A Data Reviewer Chemistry
Decatur, Illinois
Q A Data Reviewer Chemistry
Decatur, Illinois
POSITION TITLE:
QA Data Reviewer, Chemistry
DEPARTMENT:
Quality Assurance
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
6+ Years
REPORTS TO:
Director of Quality Assurance
POSITION TITLE:
QA Data Reviewer, Chemistry
EXPERIENCE:
6+ Years
DEPARTMENT:
Quality Assurance
REPORTS TO:
Director of Quality Assurance
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
The primary responsibility of the data reviewer is to ensure all source data, summary reports and documentation from the laboratory is of the highest quality, ensuring data accuracy and integrity. The data reviewer reviews all analytical data for accuracy, conformance to procedures and specifications, and proper documentation in accordance with Rising SOPs and cGMPs. The assigned individual also reviews raw data, for use of appropriate analytical instrumentation use, accuracy of calculations and conformance to all referenced analytical procedures and reviews the interpretation of the data for alignment with method validation reports and scientific legitimacy. The data reviewer reviews all electronic data audit trails in detail to ensure data integrity is not compromised in any way and ensures all signatures, electronic or written are intact prior to the release of laboratory data. The reviewer is responsible to discuss data interpretation and questions with individual analysts and elevate, if necessary, to determine data disposition.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for ensuring the integrity of all data and documentation reported from the Quality or R&D Laboratory
- Reviews all source data and associated documentation for accuracy and cGMP
- Reviews all source data for conformance to applicable specifications
- Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
- Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off.
- Responsible for verifying all laboratory testing was conducted in accordance with SOP’s as well as cGMP’s and GLP’s
- Review of Laboratory notebooks for completeness, and archival, as
- Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements
- Understands testing and procedures within Quality
- Performs work in accordance with general and specific safety precautions
- Interacts routinely with departments such as Production, QA, RA, R&D, Validation
- Works on multiple projects in a concurrent manner on a routine
- Assist in perform Quality Assurance audits on laboratory areas to ensure cGMP compliance
- Assist in the investigation and review of deviation reports and OOS reports to assure complete compliant source data.
- Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.
- Demonstrate a consistent high level integrity, professional discipline and dedication to quality compliance and improvement.
- Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension.
- Communicate regularly and effectively with all levels of the organization.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s degree in Life Sciences (e.g. Chemistry, Biochemistry, or closely related field) or Pharmacy from an accredited four-year college or university.
- 6 or more years of demonstrated excellence in an industrial laboratory related to pharmaceutical manufacturing, specializing in sterile dosage forms.
Job Prerequisites
- Excellent conceptualizing, analytical, and problem-solving skills
- Working knowledge of Microsoft Office/Excel/Access programs.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Effective written and oral communication skill;
- Strong organizational, planning, and communication skills;
- Demonstrates exceptional time management skills;
- Using logic and reasoning to identify solutions to problems;
- Ability to multi-task, set priorities, and meet strict deadlines; and
- Ability to lead, motivate, coach, and teach others.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
Q A Validation Specialist
Decatur, Illinois
Q A Validation Specialist
Decatur, Illinois
POSITION TITLE:
QA Validation Specialist
DEPARTMENT:
QA
WORK LOCATION:
Decatur, Illinois
EXPERIENCE:
4 Years
REPORTS TO:
Director of Quality Assurance
POSITION TITLE:
QA Validation Specialist
EXPERIENCE:
4 Years
DEPARTMENT:
QA
REPORTS TO:
Director of Quality Assurance
WORK LOCATION:
Decatur, Illinois
POSITION SUMMARY
Provide expertise, guidance, and oversight for the Qualification/Validation compliance at the Decatur Site. Manage site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff, and internal departments as applicable. Through technical expertise and a commitment to continuous improvement of the qualification/validation compliance, the QA Validation specialist upholds our dedication to product quality and patient safety.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide expertise in the review/approval of validation protocols and reports but not limited to steam sterilization, environmental monitoring, clean utilities, process equipment, temperature mappings, cleaning validation, process validation etc.
- Ensure the compliance of requalification schedule for facilities, equipment and processes based on a risk assessment, current industry “best practices,” and regulatory requirements.
- Responsible for ensuring the compliance state of Validation Master Plan Schedules, including facility, equipment, and process requalification’s.
- Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements.
- Able to mentor and train staff, and other resources as needed.
- Able to guide the validation team for developing applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch/manuals, if not readily available.
- Able to handle multiple, complex projects and work independently.
POSITION REQUIREMENTS
Education and Experience
- Bachelor’s Degree from a four-year accredited college or university with Major in Pharmacy, Chemistry or Microbiology or equivalent work experience in the pharmaceutical industry for at least 8 years.
- Sterile injectable experience required.
Job Prerequisites
- Ability to meet attendance standards. All full-time employees are required to work a 40 hour week, most of which has to be during “regular” business hours. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
- Excellent communication, writing, and computer skills. Ability to operate and troubleshoot validation monitoring equipment. Ability to estimate and maintain project timelines.
- Fully knowledgeable with computerized systems and programs.
Physical Demands, Mental Requirements, and Work Environment
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
Mental Requirements
- Ability to apply deductive reasoning and understand complicated issues;
- Ability to provide instructions and follow up work rules including company policies;
- Ability to ensure safety and security practices;
- Ability to accurately communicate ideas, facts, and technical information; and
- Maintain confidentiality of certain information.
Disclaimer
“The list under Essential Functions and Additional Responsibilities are not exhaustive; they reflect the primary duties of the current position as accurately as possible. Management reserves the right to revise this job description and to assign additional tasks as necessary, based on changes in the job’s requirements. This job description in no way states or implies that these are the only responsibilities and tasks to be performed by the employee in this position. Employees may be required to follow other instructions and perform other job-related duties as requested by their supervisor/manager. The requirements listed represent the minimum levels of knowledge, skills, and/or abilities needed to qualify for this position. To successfully fulfill the duties and responsibilities of this position, the employee must demonstrate proficiency in each task. Employment decisions—including promotions, transfers, and other actions—are based on meeting all job requirements, organizational needs, employee status in good standing (e.g., no active disciplinary actions), and adherence to applicable performance standards, as well as other non-discriminatory criteria. Methods of fulfilling job requirements may be modified to reasonably accommodate qualified individuals with disabilities.
THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.”
