Position Summary

The QC Microbiology Manager will report directly to quality upper management, (i.e., Director of QC) and will provide both strategic and tactical leadership as part of the QC group. The incumbent will participate in strategic and technical planning for the quality control group, and will be responsible for establishing testing timelines, executing the plan and monitoring the results. The incumbent will be responsible for 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)
• Establish and implement Environmental Monitoring Program (air, compressed gases, water, surfaces, personnel) per USP, FDA, ISO, and PDA guidelines.
• Performance and documentation of laboratory investigations
• Develop and perform Disinfectant Effectiveness Studies
• Develop and implement cleaning and sterile gowning procedures with the Operations Department
• Internal auditing and handling of external audits by customers and FDA during departmental review
• Develop and maintain cryo-stored cell line including in house identified isolates
• Purchase equipment and materials
• Hire and train staff
• Assist with autoclave and depyrogentaion oven validations
• Manage design and 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.

Education Requirements

• Master's Degree/Bachelor's degree in Microbiology or related scientific discipline with approximately 5 years industry in QC -