Quality Control Supervisor

On a rotating coverage, 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. The QC Supervisor will be responsible for directing the laboratory workflow for daily testing of isolated intermediates, finished goods, and stability and providing on-going support for these activities.

Overview:

Reporting to the Manager, QC, the QC Supervisor will provide supervisory oversight, laboratory testing support, and technical leadership for laboratory staff. The QC Supervisor will be responsible for directing the laboratory workflow for daily testing of isolated intermediates, finished goods, and stability and providing on-going support for these activities.

Responsibilities:

• Coordinate daily prioritization of QC testing, including staff and equipment utilization. 
• Maintain laboratory instrumentation, including equipment qualification, and preventative maintenance programs. May need to assist with troubleshooting and minor repairs. 
• Support training and troubleshooting efforts for staff. 
• As necessary, review completed laboratory testing to support the timely release of data, reports, and material. 
• Coordinate and oversee the status of 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 coverage, 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 required 
• Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment  
• Strong chemistry knowledge 

Qualifications:

 

• 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