Quality Control Supervisor

Responsibilities

• Cook up daily prioritization of QC testing, including staff and equipment utilization.
• Maintain laboratory instrumentation, including equipment qualification, and preventative maintenance programs.
• Support training and troubleshooting efforts for staff.
• Review completed laboratory testing to support the timely release of data, reports, and material.
• Coverage for offsite sample testing.
• Maintain and manage cGMP and general lab systems at defined levels of compliance.
• Draft and review various documents in support of laboratory efforts and production campaigns.
• Maintain laboratory systems and documentation.
• On a rotating basis, provide laboratory on-call support coverage for all aspects of laboratory operation, including environmental testing, raw material testing, in-process testing, isolated intermediate testing, and finished good product release.
• Work cross-functionally with other departments (such as Operations/Production) to ensure deliverables are met according to projected timelines.
• Verify timecards and SAP billing is completed accurately and on time as per the site-specific timelines.
• Perform the QC release for raw materials, isolated intermediates, and finished goods.
• Identify discrepancies, author out of specification and deviation investigations within TrackWise, and implement associated CAPAs.

Qualifications/Skills

• Familiarity with compliance requirements within cGMP, safety and regulatory environments.
• Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC. ICP, FTIR, UV-VIS equipment, and data stations.
• Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases.
• Strong chemistry knowledge.

Qualifications

• Familiarity with compliance requirements within cGMP, safety and regulatory environments.
• Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC. ICP, FTIR, UV-VIS equipment, and data stations.
• Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases.
• Strong chemistry knowledge.
• Bachelor's Degree in Chemistry, Pharmacy or closely related field required.
• Advanced degree highly beneficial.
• 5 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience.
• Hands on experience with pharmaceutical laboratory management required.
• Management of 24/7 lab operation highly beneficial.