Roles and Responsibilities

Prepare, review, and approve SOPs, Test Methods, Protocols, Reports, Trending Reports, Data Review, CCRs, CAPAs, Risk Assessments, etc.
Provide cGMP and lab training to the Micro staff as well as technical support and troubleshooting and train analysts in laboratory practices and standard microbiological procedures.
Lead laboratory investigations, deviations, and implementation of CAPA’s. Write and review SOP’s.
Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries service as subject matter expert, as needed.
Support process improvements and expansion growth
Develop and implement procedural guidelines within the Microbiology laboratory in conjunction with Quality Assurance.
Participate in development of cleaning validation/verification, environmental monitoring and control program, utilities, and HVAC monitoring program, sterility and microbial enumeration tests.
Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into best practices.
Work with Microbiology management to maintain environmental monitoring, testing schedules and assess testing priorities.
Monitor calibration of equipment and identify new equipment needs.
Perform other related duties as required.

Educational Qualification

Experience:

5-7 years of Experience high throughput Microbiology Laboratories is required; with at least 3 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenterals and in a CMO/CDMO/Clinical Environment).
Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods.
Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system
Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods
Must understand basic lab safety, bio-hazard and chemical waste disposal practices
Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
Knowledge of cGMP’s and understand the pharmaceutical industry expectations.
Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)

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