Chemist

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Job description

SUMMARY:
The Quality Control Chemists perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis.

ESSENTIAL FUNCTIONS:

• Physical and chemical testing of raw materials.
• Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.
• Maintaining Instrument Logbooks,
• Ensuring all testing performed is properly documented in laboratory notebook
• Performing peer review of work and documentation of other analysts.
• Maintaining the work area in an orderly manner.
• Keeps current with all SOP's required to perform their job assignments.
• Reports any problems with assays or components to the QC Lab Supervisor.
• Responsible for preparing and standardizing any reagents or standard materials required for analysis.
• Reports any supply needs to the QC Lab Supervisor and Lab coordinator.
• Disposes of unused samples and laboratory waste in appropriate containers.
• Performs calibration and verification of lab instruments as applicable per current procedures.
• Cleaning of laboratory glassware.
• Other duties will be assigned as required.

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of laboratories regulatory programs and objectives (cGMP, GLP, etc.).
• Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
• Resourceful and well organized.
• Advanced instrumentation skills, data processing and troubleshooting capabilities.
• Excellent verbal and written communication skills with proven prior experience.
• Must be able to work in a team environment.
• Must be detail oriented.
• Flexibility and adaptability in an ever-changing, fast paced environment is essential
• Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
• Possess strong math skills.
• Familiarity with GLP/GMP guidelines.
• Familiarity with out-of-specification (OOS) and out-of-trend (OOT) investigation.
• Experience with compendial procedures from USP/EP monographs.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.