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About the Role

The Microbiology Analyst II performs and reviews microbiological testing and environmental monitoring for sterile pharmaceutical products, ensuring compliance with cGMP and USP requirements. This role acts as a technical resource, supporting investigations, validations, and quality systems, while collaborating with cross-functional teams to maintain product quality and regulatory compliance.

Responsibilities

• Perform and review microbiological testing and environmental monitoring.
• Assist with performance of product validation/qualification and required protocols/documentation.
• Write/Review microbiology laboratory investigations including NONC/EE/Issue reviews/No Tests.
• Train new hires.
• Perform Sterility USP<71>, Endotoxin USP<85>, MET USP<61>/<62> testing.
• Perform and review environmental monitoring of manufacturing areas (viable air, viable surface, non-viable particulate) and inspect for compliance.
• Complete records and documents accurately and legibly, and perform accurate computer data entry/trending/presentation.
• Perform raw material, prefiltration bioburden, water sampling, and filter integrity testing.
• Conduct growth media check in and growth promotion testing.
• Prepare equipment and autoclave materials/components.
• Prepare microbial ID samples.
• Perform off testing of incubated environmental monitoring media, testing samples, and Media Fills.
• Enter/review/approve testing results in SampleManager LIMS system, INFOR, or MasterControl Electronic Batch Record.
• Use standard laboratory equipment including balance, incubator, autoclave, pipettes, and water bath.
• Support microbiology laboratory CAPA plans.
• Assist with Media Fill tracking.
• Stock and order lab supplies.
• Revise microbiology/laboratory procedures and documentation.
• Utilize a Quality Management System (QMS) for trainings and document review for procedural/policy improvements.
• Promote and maintain safe and healthy working conditions.
• Assist in the cleanliness and upkeep of the laboratory.

Requirements

• Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, Medical Technology, or related life science required.
• Minimum of 2 to 3 years relevant experience in a microbiology laboratory within an FDA regulated biopharmaceutical/medical device industry.
• An Associate's degree in a scientific field with a minimum of 3 to 4 years relevant experience may be considered.
• Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown.
• Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines.
• Working knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial Enumeration testing methods is preferred.
• Accurate and legible completion of records and documents for tests performed.
• Accurate computer data entry.
• Good time management skills.
• Attention to detail.
• Ability to adhere to implemented standard operating procedures/policies.
• Ability to communicate professionally with contract laboratories regarding sample testing.
• Ability to communicate with others.
• Flexibility for new opportunities/tasks.
• Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology is preferred.
• Experience with standard laboratory equipment including balance, incubator, autoclave, pipettes, or water bath is preferred.
• Knowledge of ISO, USP or GMPs standards is a plus.
• Knowledge of computer skills (e.g. Windows, Word, Excel, Power Point).
• Excellent time management skills.
• Excellent attention to detail.
• Understanding of Quality requirements and Pharmaceutical Regulations including, but not limited to 21CFR211, 21CFR11, Good Documentation Practices, and ALCOA+.
• Ability to adhere to standard operating procedures and policies.
• Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required.
• Able to work independently and as a team.
• Flexibility based on demand/workload.
• Must have a reliable method of transportation for work.
• Ability to wear high level full body aseptic gowning with face mask for long periods of time.
• Ability to stand for long periods of time.

Skills

• Microbiological testing
• Environmental monitoring
• cGMP compliance
• USP requirements
• Laboratory investigations
• CAPA support
• Validation support
• Media fill programs
• Quality system activities
• Method validation
• Method qualification
• Procedure revision
• Personnel training
• Continuous improvement
• Sterility testing (USP<71>)
• Endotoxin testing (USP<85>)
• Microbial Enumeration testing (USP<61>/<62>)
• Aseptic gowning
• Computer data entry
• LIMS system usage (SampleManager)
• Electronic batch record systems (INFOR, MasterControl)
• Standard laboratory equipment operation
• Microbial ID
• Clean room technology
• Good Documentation Practices
• ALCOA+
• Problem-solving
• Issue resolution
• Prioritization
• Microsoft Windows
• Microsoft Word
• Microsoft Excel
• Microsoft Power Point

Location

• Onsite

Work Type

• Full-time

Experience Level

• 2-3 years relevant experience
• 3-4 years relevant experience (with Associate's degree)

Education Level

• Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, Medical Technology, or related life science
• Associate's degree in a scientific field