Quality Control Microbiology Analyst

The Analyst, Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.

The Analyst, Quality Control - Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility.

Job Description Responsibilities :

• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
• Conducts routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes.
• Document laboratory test results in GLIMS, worksheets, forms, and logbooks utilizing Good Documentation Practices in a timely manner.
• Assists in drafting and revising SOPs and reports.
• Manages the use and maintenance of scientific equipment and instrumentation, computer systems.
• Responsible for limited range of laboratory support functions and procedures as assigned, developing capability in basic technical skills, disciplines, and procedures within assigned discipline area(s).
• May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook / equipment use and maintenance, and updates to existing operating procedures.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
• Notifies management and initiates events (such as Laboratory Investigations) in the quality systems, with guidance from senior analysts or management.
• Assist in special projects on analytical and instrument problem solving by execution of assay.
• Gain familiarity with basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
• Other related job duties as assigned.

Requirements :