Supervisory Responsibilities:
- Hires and trains quality control staff.
- Oversees the daily workflow and schedules of the department.
- Conducts performance evaluations that are timely and constructive.
- Handles discipline in accordance with company policy.
Duties/Responsibilities:
- Lead, coach and develop the QC personnel (analysts, chemists and/or microbiologists) to ensuring that analytical testing (chemical, physical and/or microbiological) and data review is performed in a safe and reliable manner to support manufacturing operations across all shifts with adherence to site Standard Operating Procedures (SOPs).
- Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), Good Manufacturing Practices (GMP).
- GMP release of incoming consumables, raw materials, and critical reagents & finished products.
- Documentation of GMP release activities.
- Handle/Manage Quality Events such as Deviations, Investigations, Change Control, CAPA, Risk/Gap Analysis
- Method development, Method Validation and Method Transfer for incoming consumables, raw materials & finished products.
- Qualification of raw materials for clinical and commercial manufacturing.
- Manage/Implement Lab Compliance Activities such as Lab Audits/Inspections.
- Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods or stability samples.
- Check quality of batches of finished products to ensure they meet all company quality & GMP standards.
- Inspect all product returns, analyze the defect, and document the findings.
- Verify all processes are conforming to established quality standards and required customer specifications.
- Auditing visual, dimensional, and mechanical tests of materials and processes.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Investigate customer complaints regarding quality issues and develop a solution.
- Assist with auditing, writing, revising and verifying quality standards and developing forms and instructions for recording, evaluating and reporting quality data.
- Monitor performance of quality control systems to ensure effectiveness and efficiency.
- Produce reports regarding non-conformance of products or processes, daily production quality, root cause analyses, or quality trends.
- Participate in the development of product specifications.
- Implement quality control training programs.
- All other duties as assigned by Senior team.
