- Perform all levels of testing including environmental monitoring of manufacturing areas, microbiological and chemical analysis of water samples, product bioburden testing, endotoxin testing, IPT testing, ID testing and QC testing of media.
- Provide guidance to the QA Microbiology group and assist Department planning on a day to day basis. Conduct all laboratory duties in a manner consistent with cGMP
- Write, review and revise SOP’s and/or work instructions for any cGMP activities
- Guide others on SOP’s, control documents, and work instructions.
- Support and coordinate QA Microbiology Validation and Qualification activities. May write & execute validation protocols.
- Write, review and approve SOP’s and review job related technical documentation.
- Write, review and approve NC’s, CAPA’s and QCR’s and close out all documentation types within the defined due dates.
- Write, review and approve documentation needed for qualification of equipment and processes to support the QA department.
- Interact with and support all regulatory agency site audits and inspections.
- Interpret quality standards to insure all tests comply with requirements.
- Help develop and execute QA Department level initiatives.
- Prepare documentation of actions and results and ensure proper documentation during job activities. Prepare ad hoc reports and summaries as needed.
- Support non-routine analysis, investigations and studies with little supervision.
- Assist improvement activities and cross functional teams to meet strategic goals.
- Conduct troubleshooting activities and analysis of trends to aid and identify root causes and/or identify solutions or improvements to processes.
- Monitor key performance indicators and maintain accurate and complete trend analysis with visual tracking to enhance audit readiness and for management review.
- Train others on systems, software, equipment, and procedures as needed.
- Assess and implement improvements for the department which have a positive effect on waste generation, quality and cost.
- Conduct presentation for the department to diverse audiences.
Scope of Position:
Primarily supports Clearwater & Surgical Quality. May be requested to support other Bausch & Lomb facilities as needed.
Internal: Functional representatives within Bausch + Lomb facilities
External: Suppliers, external auditors/regulatory authorities.