QC Manager Fenton, Missouri
Job Ref: 36422
The Manager, Quality control, oversees and manages total Quality Control (QC) operations. This role plans, coordinates, and directs Quality Control program designed to ensure quality production of products consistent with established standards. Qc manager manages and supervises the daily function of Quality Control and assists with the release of materials, components and drug products, responsible for specifications and other quality activity such as method validation, method verification and transfer. Supports regulatory filings.
- Responsibilities include hiring, and training employees; planning, assigning, directing work; appraising performance of employees.
- Sets and deliver on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions.
- Contributes in preparation and monitoring of budgets through regular analysis of cost and spending.
- Capable of writing and reviewing deviations, out of specification /lab investigations, and corrective/preventative actions (CAPA) lab investigations utilizing tools like 6M, 5 Why’s etc.
- Responsible for regulatory audit responses.
- Implement and manage QC related SOPs and processes. Monitor data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records.
- Responsible for timely testing and releases of raw materials, in-process, finished products, stability samples from the lab.
- Responsible for reviewing changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
- Attends production planning meeting and updates and track list with delivery dates committed.
- Oversee and manage Raw Material Program.
- Oversee and manage Alkem’s Stability Program as per regulatory guidelines.
- Oversee and manage calibration, maintenance of instruments to reduce break down.
- Complete other duties as requested by senior management.
- A fundamental, working knowledge of safety, quality systems, and quality control concepts is required including the application of cGMP.
- Strong understanding of GXP as it pertains to 21 CFR 210, 211 regulated environments, various regulatory bodies and product filing.
- Strong computer skills in database management and documentation preparation (LIMS, SAP, DMS, Trackwise etc.)
- Strong technical knowledge of various formulation but not limited to Tablets, capsules, ointments, oral liquids, nasal spray.
- Strong analytical knowledge of various instruments but not limited to HPLC, GC, Dissolutions, Wet chemistry etc.