Job Description
Metric Bio is partnered with a very exciting Pharmaceutical Company. They are currently looking for an Quality Control Chemist to come in to their facility in the surrounding Baltimore area. Someone that can provide analytical support and data generation for daily chemistry testing activities related to raw materials, in- process and finish products. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (test methods, Specifications, SOPs).
Responsibility:
- Conduct release, stability, and special request testing on finished products and raw materials, adhering to Standard Operating Procedures (SOPs), in-house test methods, and/or compendial guidelines.
- Provide training on the operation of various instruments, including but not limited to: Laboratory Balances, High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, and Dissolution/Disintegration Instruments. Additional training may be required for new laboratory test methods and equipment as needed.
- Stay up to date with publications from the USP, FDA, and other relevant regulatory bodies to ensure compliance with Quality Control laboratory standards for analytical applications, release specifications, and documentation practices.
- Support QC management and/or designee in investigating and resolving Out-of-Specification (OOS) results in the laboratory. Effectively communicate with QC management, the Out-of-Specification/Trend Coordinator regarding suspect results, and the Stability Coordinator when necessary.
- Assist in training new laboratory staff and ensure proper documentation of training in line with established laboratory SOPs and the training program.
- Adhere to Current Good Manufacturing Practice (cGMP) documentation guidelines to ensure timely and accurate record-keeping of all procedures.
- Ensure a safe working environment and verify that all equipment used in testing procedures is properly calibrated and maintained.
- Complete specific projects assigned by management and perform other necessary functions to meet company objectives.
- Communicate effectively across departments and collaborate within a team-oriented environment.
- Regular attendance is required.
Qualification:
- 3+ years of experience in a cGMP facility
- Bachelors of Science of Bachelors of Arts in a science related field like Chemistry, Biochemistry or Biology. Prefer Chemistry but are open to others mentioned.
- Experience with instrumentation such as GC & LC, HPLC, UV-VIS-FTIR spectroscopy, TOC, thermal and mechanical analysis (e.g. DMA, DSC, etc); wet chemistry techniques desired.
- Microbiology experience is a plus
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