Quality Control Specialist

Position Responsibilities: Responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs. Demonstrate mastery of data management/documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintain positive site relations; support internal and third-party manufacturing/packaging sites. Assure compliance with FDA and GMP regulations. Influence cross-functional teams (Global Support and external organizations) and act as a recognized resource. Key Functions: Work independently and as a team member; support objectives aligned with site goals. Initiate/lead problem solving to prevent repeat issues, reduce lab downtime, and improve reliability. Escalate safety/quality events per standard work. Timely approval of qualification, change control, procedures, and other documents. Perform stability and plant site release and study approvals. Support GLIMS updates; review builds and IPI specification verification; review technical memos and testing protocols. Attend stability data review/reporting meetings; serve as liaison among teams, leadership, and external entities. Interpret quality policies/guidelines for daily application; participate/direct tier meetings. Provide statistical summary analysis for Annual Product Reviews (APR). Education Requirements: BS in Chemistry, Biology, or Engineering; ≥ 2 years in a pharmaceutical laboratory setting. Required Experience/Skills: Prior pharmaceutical laboratory experience. Knowledge/experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Required Skills: Adaptability; analytical instrumentation; analytical method development; dissolution testing; continuous improvement; GMP compliance; Karl Fischer titrations; laboratory documentation/safety; microbiological analysis/testing; teamwork; technical writing; troubleshooting; use of lab equipment. #J-18808-Ljbffr