Summary: Performs complex testing of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions, and maintains appropriate records.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Conducts scheduled preventive maintenance and calibration of equipment (i.e., pH meter, HPLC, dissolution equipment, etc).
- Prepares standard and sample solutions as required by the test methods.
- Operates general analytical instruments during routine testing (i.e., HPLC, GC, UV, automatic titrator, IR, AA and TLC).
- Performs wet Chemistry tests (i.e., LOD, pH, titration, etc.).
- Performs analysis on intermediate and finished products.
- Maintains appropriate documentation (records and lab notebooks) as required by SOP’s.
- Complies with all current Good Manufacturing Practices (cGMP) current Good Laboratory Practices (cGLP) and safety requirements, laboratory Standard Operating Procedures (SOPs) and Company policies and procedures.
- Complies with good housekeeping and safety practices.
- Participates in troubleshooting of analytical test methods and laboratory instruments.
- May perform peer review of other chemist’s work.
- Takes part in the training program as a qualified trainer, as requested.
- Performs related duties as assigned.
Required Knowledge and Skills:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Up-to-date instrumentation and the following instruments: UV/IR, HPLC, GC and TLC.
- Chemistry and wet chemistry.
- Computer applications and programs related to laboratory applications (i. e., HPLC, FTIR, AA).
- Quality control systems.
- Math including statistics.
- Sample preparation techniques.
- Spectroscopic techniques.
- Chromatographic system.
- Compliance with DEA