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Job Description :
The Microbiology Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and endotoxin testing. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and cGMP regulations. They typically work with a team of 5 – 15 other Associates within the functional Quality Control laboratory and the Manufacturing area.
- Participate in manufacturing facility commissioning and qualification.
- Perform compressed gas sampling and Routine Environmental Monitoring of classified areas within the manufacturing facility.
- Perform endotoxin testing.
- Participate in gown qualification and requalification of personnel.
- Create, review, and approve relevant QC documents, SOPs, and WIs.
- Support Aseptic Process Simulations and visual inspection of components.
- Utilize electronic systems (eLIMS) for execution and documentation of testing.
- Perform peer data review/approval of laboratory data.
- Initiate quality investigations related to environmental monitoring.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Required Qualifications :
- Minimum of a Bachelor’s or equivalent University degree required; focused degree in Biological Science or equivalent technical field preferred
Experience and Skills:
- Minimum two (2) years of relevant work experience
- Experience within the biological and/or pharmaceutical industry
- Microbiology experience related to manufacturing
- Detailed knowledge of Microbiology testing and sampling methods, techniques, and related equipment
- Aseptic processing in ISO 5 cleanroom
- Knowledge of cGMP regulations and Good Documentation Practices (GDP)
- Excellent written and verbal communication skills
- Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision
- Knowledge of Microbiology laboratory techniques such as endotoxin testing, sterility testing, bioburden testing, growth promotion testing, and/or microbial isolation
- Experience working with cell therapy
- Knowledge of FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices (GTP)
- Trending using statistical analysis