QC Scientist
1 month ago
The successful candidate will be responsible for managing quality records, ensuring inspection readiness, and supporting the development of procedures for full compliance.
Responsibilities:
Oversee all quality records in Quality Control and ensure timely completion. Participate in regulatory inspections and submissions. Generate protocols and reports for assay transfers/validation. Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP). Lead or assist with OOS, OOT, and lab investigations as needed. Lead QC laboratory equipment introduction and participate in validation activities. Communicate QC requirements within internal and across other functional groups. Perform QC testing following Standard Operating Procedures (SOPs). Assist with the maintenance of QC laboratory and equipment. 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. Manage technical studies performed with external companies. Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
Key Skills and Requirements:
A BA or BS in Chemistry/Biochemistry/Microbiology or other related science. Proficiency in GLP / GMP in a relevant work environment. Computer literacy (including MS Word and Excel) Ability to work well within a team and independently. Effective communication skills Good organizational skills
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