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• Monitor quality control activities overall. Conduct laboratory investigations and evaluations to ensure compliance with SOPs, FDA, DEA, ANDA, and OSHA regulatory guidelines.
• Always maintain the cGMP and GLP practices in the Quality control laboratory.
• Write and review investigation reports, proposed CAPAs, deviations, risk analyses, and reports to identify root causes using IQ/OQ/PQ, QMS, and Change Control.
• Through investigating all lab investigations per regulatory guidelines, identify root causes and define proper corrective and preventive actions to avoid reoccurrence.
• Procurement of lab instruments, accessories, and chemicals per project needs. Qualification and Calibration of Quality Control Laboratory Instruments and Equipment. Coordinate with other departments, such as QA and production, on all QC activities related to raw material, in-process, finished product, and stability testing.
• Review and ensure all laboratory records and documentation are maintained per cGMP and GLP/GDP guidelines.
• Review and update all QC documents per current regulatory guidelines. Ensure all QC Laboratory records and documentation are maintained per cGMP and 21 CFR 211.194 guidelines.
• Coordinate and provide the required technical expertise in installing and commissioning new instruments/equipment in the Quality control laboratory.
• Responsible for improving the technical skills of QC analysts by providing training on different topics like analytical techniques, good laboratory practices, good documentation practices, Data integrity, etc.
• Responsible for building a new Quality Control team and establishing a GLP-compliant Quality Control lab for a commercial manufacturing site. This includes analytical, microbial, technical services, stability, and sample management groups for sterile pharmaceutical products.
• To ensure timely testing, provide direction for analytical, microbial, technical services, and sample management groups.
• Ensure laboratory equipment and utility qualifications, appropriate qualification/validation of analytical methods, and method transfer and validation between manufacturing sites.
• Ensures QC Systems and practices are developed and implemented under the cGMP requirements.
• Establishes and publishes Key Performance Indicators to track cGMP compliance for the Quality Control function.
• Works with senior stakeholders to develop plans and strategic direction for the team.
• Collaborate with FDA as needed, representing the firm to authorities and regulatory inspectorates in matters relating to GMP.
• Supports standardisation and harmonisation of Standard Operating Procedures.
• Participate in laboratory inspections and audits.
• Direction of QC functional groups to ensure timely testing.
• Oversight of laboratory training programs.
• Responsible for conducting laboratory investigations, OOS, and OOT.
• Generation of CoAs for product release.
• Draft analytical and stability sections of regulatory submissions.
• Monitor and trend data while assembling reports on product release test monitoring of the company’s cGMP facility.
• Frequently update stakeholders on trends.
• Implement corrective action plans.
• Tracking of data from external contract laboratories to complete lot disposition.
• Establish user requirements for the purchase and qualification of QC analytical equipment.
• Work with internal and external resources to maintain equipment in an efficient state.
• Develop, revise and review SOPs, qualification/validation protocols, and reports.

• Schedules, oversees, and performs Preventative Maintenance (PM) and Calibration on all production and facility equipment at the Grand Avenue and Wyckles Road facilities.
• Plans semi-annual maintenance shutdown scheduling and planning.
• Maintains the computerized maintenance work order system and calibration tracking system including creation and update of all PM, Work Orders and Calibration.  Ensures PMs, Work Orders and Calibration forms are issued and assigned in a timely manner.  Ensures new users are trained.
• Most of the incumbent’s time is spent finding the best solution to maintenance and instrument related problems, performing investigating because of deficiencies, and implementing corrective and preventive actions.

• Support equipment, system and facility modifications and upgrades for automated process efficiency, regulatory compliance and replacement of obsolescent equipment, controls and systems.
• Demonstrate technical knowledge to write detailed work orders / investigations related to facility equipment and systems and process equipment.
• Provide leadership and support for continuing process improvement efforts for other functional groups. This shall include the execution of projects which benefit efficiency and/or productivity, supporting project justification analysis, program preparation, project implementation, scheduling resources, and support engineering for cost tracking.

• Enhance the mechanical, electrical, and electronics skills within the department.  Provide technical resources to departments within the organization regarding facilities, controls, systems and equipment improvement based upon the departmental systems used to facilitate the workload.
• Represent and foster harmonious relationships both inter and intra-departmentally.
• Maximize software capabilities to perform job duties and analyze data for tracking and trending.
• The position also requires “Hands-on” maintenance activities to train and assist technicians.
• Interface with external organizations such trade contractors, equipment suppliers, and service providers.
• Responsible for housekeeping function, either directly or through direct reports.
• Familiar with Injectable and utility equipment maintenance, operation and troubleshooting, including but not limited to, Vial washer, Tunnel, Vial filling machine, Isolator, Capper, Vial Labeling, Inspection machine, Track and Trace, Capper, Parts washer, Autoclave, Vessels, WFI Generation & Distribution, Pure steam Generator & PW system.
• Very well equipped with SOP writing skills for Change control, CAPA, deviation and Investigation

• Routinely maintains, troubleshoots, and develops application solutions for automated electromechanical systems and software.
• Experience in a senior level position with planning, scheduling, and organizing project activities.
• Performs corrective maintenance on facility and production equipment including, but is not limited to PLCs, vision systems, SCADA system development, automated packaging equipment, and high purity utility systems.
• The incumbent may be required to work any shift and may be required to work both scheduled and unscheduled overtime.  The incumbent may be required to carry and respond to a cell phone, pager, or radio.
• Work with all departments to support the manufacturing operations and to improve methods for automated data collection and reporting, and overall reliability and performance of equipment and systems.  This includes existing systems and new installation projects.  Keep an open line of communication across departments and managerial lines.
• 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.
• 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.

• 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.

• 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.

Analytical Testing and Instrumentation

• Perform tests on raw materials, in-process samples, and finished products to confirm they meet specified standards.
• Utilize various analytical instruments, including HPLC, GC, UV-Vis, FTIR, and titrators, for chemical compound analysis.
• Support the development and validation of new analytical testing methods.
• Regularly calibrate and maintain analytical instruments for proper functionality.

Toxicology and Safety Analysis

• Keep the laboratory clean and organized, handling chemicals safely.
• Share test results and findings with relevant departments to aid in product enhancement.

Product Stability Testing and Shelf-Life Assessment

• Conduct stability testing on products to determine shelf life and ensure they retain quality over time.
• Analyze data to detect degradation and assess product safety and efficacy.

Data Management and Documentation

• Ensure that methods are robust, accurate, and effective for quality assurance.
• Accurately record, review, and report test results, maintaining documentation per company and regulatory standards.
• Keep detailed records in lab notebooks and electronic systems for traceability.

Regulatory Compliance and Quality Standards

• Adhere to GLP standards to ensure test results are reliable and consistent.
• Stay informed on regulatory guidelines, including GMP and FDA standards.
• Ensure lab processes are compliant to maintain certification and audit readiness

Problem-Solving and Continuous Improvement

• Identify deviations and troubleshoot issues to uphold quality standards.
• Participate in root cause analysis and investigations of any out-of-specification (OOS) or out-of-trend (OOT) results.
• Recommend corrective actions to prevent quality issues from recurring.
• Address equipment malfunctions and coordinate with maintenance teams as needed.
• Engage in continuous improvement initiatives to boost testing efficiency and quality.
• Propose improvements in testing procedures, safety protocols, and lab practices.

• 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.