Position Summary:
The Microbiology Analyst II is responsible for performing and reviewing microbiological testing and environmental monitoring activities to support the manufacture and release of sterile pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), applicable USP requirements, and company procedures. This role performs routine and advanced microbiological analyses, supports laboratory investigations, CAPAs, validations, media fill programs, and quality system activities to ensure product quality and regulatory compliance.
The Microbiology Analyst II serves as a technical resource within the laboratory by reviewing data, assisting with method validations and qualifications, revising procedures, training new personnel, and supporting continuous improvement initiatives. This position collaborates closely with Quality Assurance, Manufacturing, and Quality Control management while maintaining accurate documentation, promoting a safe laboratory environment, and ensuring compliance with all regulatory and company requirements.
Essential Functions:
- Assist with performance of product validation/qualification and required protocols/documentation.
- Write/Review microbiology laboratory investigations including NONC/EE/Issue reviews/No Tests.
- Training of New Hires.
- Perform Sterility USP<71> (or equivalent), Endotoxin USP<85>, MET USP<61>/<62> testing.
- Perform and review environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
- Accurate/legible completion of records and documents for tests performed, and accurate computer data entry/trending/presentation.
- Perform raw material, prefiltration bioburden, water sampling, and filter integrity testing.
- Growth media check in and growth promotion testing.
- Equipment preparation and autoclaving of materials/components.
- Preparation of microbial ID samples.
- Off testing of incubated environmental monitoring media, testing samples, and Media Fills.
- Required entry/review/approval of testing results in SampleManager LIMS system, INFOR, or MasterControl Electronic Batch Record.
- Use standard laboratory equipment including but not limited to balance, incubator, autoclave, pipettes, and water bath.
- Support microbiology laboratory CAPA plans.
- Assist with Media Fill tracking.
- Stocking/ordering lab supplies, when needed.
- Revision of microbiology/laboratory procedures and documentation.
- Utilization of a Quality Management System (QMS) for trainings and document review for procedural/policy improvements within the department.
- Responsible for promoting and maintaining safe and healthy working conditions in assigned work area; instructs and enforces compliance with established safe work practices and procedures; support training of new personnel and ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
- Responsible for assisting in the cleanliness and upkeep of the laboratory.
- May perform other duties as qualified/assigned.
Education and Experience:
- Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, Medical Technology, or another related life science required with a minimum of 2 to 3 year relevant experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry. An Associates degree in a scientific field with a minimum of 3 to 4 year relevant experience, may be considered.
- Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown upon completion.
- Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial Enumeration testing methods. (preferred)
- Accurate/legible completion of records and documents for tests performed, and 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, communication with others, and flexibility for new opportunities/tasks.
- Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology 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)
Knowledge, Skills and Abilities:
- 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
Physical Requirements / Working Conditions:
- Must have a reliable method of transportation for work. (required)
- Ability to wear high level full body aseptic gowning with face mask for long periods of time. (required)
- Ability to stand for long periods of time. (required)
Pay: From $24.00 per hour
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
