Perform the receipt and logging of incoming pharmaceutical ingredients
Perform the sampling of incoming pharmaceutical ingredients for internal laboratory testing and shipment to external contract laboratories for testing
Perform internal laboratory testing (e.g., organoleptic tests, identification (FTIR), pH, viscosity, specific gravity, chemical assays (HPLC), etc.) on incoming pharmaceutical ingredients, in-process samples, finished products and stability samples
Calculate adjustments for in-process bulk product
Prepare and review internal laboratory testing and external contract testing laboratory reports for raw materials, in-process samples, finished products and stability samples
Prepare and review Certificates of Analysis
Notify manager immediately of non-conforming data or unexpected occurrences
Conducts laboratory investigations under the supervision of the laboratory supervisor
Prepare and/or review test procedures, SOPs and protocols as assigned.
Prepare and review IQ/OQ/PQ Protocols for production and laboratory equipment
Perform IQ/OQ/PQ testing on production and laboratory equipment
Complies with all regulatory/in-house requirements which may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP documentation
Requirements
Combination of advanced degree (such as Bachelors in Chemistry or related science) and 3+ years of experience in high volume manufacturing preferred; extensive years of experience in lieu of advanced degree is acceptable
Previous experience within a cGMP compliant facility, Quality Control and USP Standards preferred
Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
Excellent analytical and problem-solving skills
Excellent time management and organizational skills
Ability to work effectively in a fast-paced, rapidly changing environment
Excellent people skills, with demonstrated ability to communicate effectively across functional groups