Quality Control Chemist backup

Position Title: Quality Control Chemist 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.

Essential Duties and Responsibilities:
• Sampling and testing of raw materials per approved procedure.
• Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.
• Upkeep of laboratory notebook.
• Maintaining the work area in an orderly manner.
• Maintaining Lab inventory like list of standards, chemical, reagent etc.
• Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc.
• Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.
• Perform Finished product/in-process/cleaning validation and raw material analysis independently. Complete testing within specified timeframes and document results accurately
• Coordinate with vendor for instrument PM, calibration and qualification activity. Provide necessary support.
• Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc.
• Performs calibration of lab instruments whenever possible.
• Cleaning of laboratory glassware.
• Responsible for writing SOP for instrument operation/ calibration etc.
• Provide necessary support for OOS/OOT investigation.
• Preparation of stability schedule, Protocol, and report per ICH requirements.
• Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation.
• Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure.

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.

Job Prerequisites:
• 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.

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.
• Requires eye-hand coordination and manual dexterity. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.
• Will come in contact with hazardous materials. Employee is expected to work with hazardous materials in a safe manner and use all safety precautions.

Mental Requirements:
• Effective written and oral communication skills.
• Strong organizational, planning, and communication skills.
• Using logic and reasoning to identify solutions to problems.
• Ability to multi-task, set priorities, and meet strict deadlines.
• Ability to lead, motivate, coach, and teach others.
• Ability to accurately communicate ideas, facts, and technical information.
• Ability to meet deadlines and effectively deal with office stress.
• Ability to follow safety and security practices.
• Ability to receive instructions and follow work rules and company policies.

• The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.

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