Senior Quality Control Specialist
4 weeks ago
This role is responsible for ensuring the quality of our products by performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The ideal candidate will have a strong background in a relevant science and experience in a GLP/GMP environment.
Key Responsibilities
Perform QC testing following SOPs and cGMP guidelines
Assist with the maintenance of the QC laboratory and equipment
Generate protocol and report for assay transfers/validation
Review and complete documentation in accordance with cGMP
Author and review SOPs, forms, Deviations, Change controls CAPA, CoA reports
Lead or assist with OOS, OOT, and lab investigations as needed
Participate in regulatory inspections and submissions, as needed
Lead QC laboratory equipment introduction and participate in validation activities
Interact within internal as well as across other functional groups to communicate QC requirements
Manage receipt and storage of QC samples, reagents and maintain retain inventory
Coordinate shipping of samples to contract testing laboratories
Train others within the department for methods and processes according to GMP standards
Become SME/Trainer for method or process and lead troubleshooting or method optimization as required
Line management responsibility for direct reports if applicable
Preferred Qualifications
BA or BS in Chemistry/Biochemistry/Microbiology or other related science
4 years or more GLP/GMP experience in a relevant work environment
Computer literacy (including MS Word and Excel)
Ability to work well with others
Effective communication skills
Good organizational skills
Location
This position is based in our Milton Park location and typically has a 5-day on-site expectation.
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