What are the responsibilities and job description for the Group Lead, Microbiology position at Exela Pharma Sciences?
Position Summary
The QC Microbiology Group Lead will report directly to Microbiology management, (i.e., QC-Microbiology Supervisor) and will provide both laboratory and/or environmental monitoring leadership as part of the Microbiology group. The incumbent will participate in technical planning of day-to-day lab and environmental monitoring activities, and will be responsible for establishing testing and sampling time lines, executing the plan and monitoring the results. The incumbent will assist leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration. The individual will be responsible for implementing policies and procedures that improve safety and productivity.
Job Responsibilities
- Write and Implement Standard Operating Procedures according to cGMP and cGLP.
- Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin, AET, etc. per USP and FDA guidance)
- Execution of Environmental Monitoring Performance Qualifications (EMPQ)
- Performance and documentation of laboratory investigations
- Develop and implement cleaning and sterile gowning procedures with the Operations Department
- Internal auditing and assistance in handling of external audits by customers and FDA during departmental review
- Purchase equipment and materials
- Assist in Hiring and develop training plans for staff
- Assist in the performance of Media Fills with input from Quality Assurance, Validations, and Operations
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
Experience and Education Requirements
Bachelor’s degree in Microbiology or related scientific discipline with approximately 3-5 years industry in QC - Microbiology experience. Previous leadership roles preferred.
