Amneal Pharmaceuticals, LLC Supervisor, Quality Control in Piscataway, New Jersey
Schedule testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities. Ensure timely testing and releases of raw materials, in-process, finished products, stability samples from the lab. Initiate change controls for revisions to any controlled document (SOPs, methods, stability protocol, and specification) applicable to quality laboratory. Review changes in compendial methods for applicable products and notify management of such changes in order to determine appropriate course of action. Drive effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, US Pharmacopeia (USP), and current Good Manufacturing Practices (cGMP). Help analysts by troubleshooting methods, instrumentation, and execution of the tests. Initiate Out of Specifications/Out of Alert Limit investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepare reports of investigation, method transfers, method verification/validation where required. Ensure laboratory personnel complete weekly worksheets, review worksheets with respect to schedules, and submit completed worksheets. Review method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identify training needs and provide necessary training to the analysts as and when needed.
Master’s degree or foreign equivalent in Chemistry, Pharmaceutical Chemistry or related field
Three (3) years of experience in the position offered or related occupation.
Bachelor's degree or foreign equivalent in Chemistry, Pharmaceutical Chemistry or related field and five (5) years of progressively responsible post-baccalaureate work experience in the position offered or related occupation.
Two (2) years supervisory experience; analytical chemistry techniques including spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by differential scanning calorimeter (DSC)); compendial (USP, European pharmacopeia, British pharmacopeia, or Japan pharmacopeia) procedures; cGMP requirements applicable to quality control laboratory; troubleshooting and resolving analytical and instrument-related problems; and identifying trends in analytical data.
Amneal Pharmaceuticals LLC 1 New England Ave., Piscataway, NJ 08854. Attn: HR Ref: \# 12290