Supervisor, Quality Control

Supervisor, Quality Control prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, & SOPs applicable to laboratories, conducts lab investigations when needed, participates in cross-functional teams to understand priorities, commits & delivers as committed. Schedules testing/review of raw materials, in-process, finished product, & stability samples, complaint samples, samples from process & cleaning validation activities; assignments shall be in writing & a day in advance. Drives effective & efficient shop floor supvn enforcing compliance to data integrity, SOPs, specs, methods, USP, & cGMP through real time verifications of records, LNB, logbook, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation & execution of the tests. Initiates OOS/ OOAL investigation, participates in investigation activities, & closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/ validation where reqd. Ensures implmtn of CAPA, as identified during the investigations. Ensures timely testing & releases of raw materials, in-process, finished products, stability samples from the lab. Reviews & approvals, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, & other analytical records as needed. Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol, & specification) applicable to qlty lab. Reviews changes in compendial methods for applicable products & notifies mgmt of such changes in order to determine an appropriate course of action. Identifies training needs & provides necessary training to the analysts as & when needed. Participates in analysis as & when reqd for special projects. Must have at least a bachelor's deg in Pharmacy or Chemistry or Pharmacology. Must have 12 mos of exp in the position or in a rltd role. Job Loc: Branchburg, NJ. Send resumes to: Amneal Pharmaceuticals LLC, 65 Readington Rd., Branchburg, NJ 08876. Attn: HR. REF# 13001