Supervisor, Quality Control M/F/D Job at seqens
Job Family / Sub-family
Quality & Regulatory - Quality Control
Contract type
Permanent
Job title
Supervisor, Quality Control M/F/D
Position Context:
Ø Purpose of the position:
Leader who can build and maintain a top-notch QC function with successful outcomes from the agency, auditors, and customers.
Leader who can build and maintain a top-notch QC function with successful outcomes from the agency, auditors, and customers.
Main tasks :
Ø Main missions:
- Proactively performing and maintaining QC function in full compliance with cGMP, ICH, EHS, and PCI guidelines.
- Scheduling workflow and supervising / training QC Analysts.
- Perform testing.
- Overseeing and lending support to laboratory personnel in testing raw materials, in-process samples, finish product, clean-out, and stability samples, daily.
- Troubleshooting, maintaining, procuring, and installing various analytical instruments.
- Participating actively on cross functional improvement initiatives.
- Conducting lab Out of Specification (OOS), Out of Tolerance (OOT), Quality Investigation (QI), Laboratory Investigation Report (LIR) , and material non-conformance investigations.
- Overseeing the transfer of validated methods from Method Development group to Quality Control laboratory.
- Attend daily huddle meeting, other meetings, and ensure the department is proactively ready for all the daily and weekly activities (staffing, supplies, reagents, standards, materials; and delivering accurate results in a timely manner).
- Conducting hands-on training for all QC analysts and technicians.
- Communicating well with all parties, to deliver accurate results, and informing all parties with the time frame.
Required skills :
Bachelor's in Chemistry or a related field.
3-5 years experience
Experience supervising employees in a cGMP in QC department.
Prior experience with writing / investigating LIR, QI, CAPA, peer review, and prior experience interacting with QA is essential.
Passion, drive, commitment, entrepreneurial orientation, people management.
Solid understanding of CDMO API organization is a plus.
cGMP, and GDP guidelines, and practices (content expertise, metrics-orientation, flexibility).
Position location
Job location
USA, Massachusetts, Newburyport
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