Job Title: Microbiologist Quality Control Associate

Reports to: Chief Quality Officer

Overview:
We're looking for a detail-oriented Microbiologist Quality Control Associate to help ensure our products meet company and regulatory standards. You’ll inspect products prior to us, during and after production, keep records, and support quality documentation tasks.

This role is hands-on and works closely with our production team.

• Perform microbiological testing (endotoxin, sterility, and bioburden) for raw materials, in-process materials, intermediates, and final products.
• Perform microbiological testing (endotoxin, bioburden) for utilities such as water.
• Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests).
• Perform growth promotion testing for all incoming media used in the microbiology laboratory.
• Perform microbial limits/enumeration testing and handle QC microbiological sample receipt, including internal testing, logging, processing, tracking, distribution of test results, and closure.
• Author and revise controlled documents, including Standard Operating Procedures (SOPs), Investigational Protocols, Risk Assessments, and others as needed.
• Initiate Out of Specification (OOS) or Environmental Monitoring investigations, 
  recommend appropriate Corrective and Preventive Actions (CAPAs), and complete effectiveness checks.
• Act as a liaison with vendors for maintenance, preventive maintenance (PM), and calibration of equipment.
• Ensure general laboratory housekeeping and maintain a clean, organized workspace.
• Facilitate the revision and release of all controlled documents in a timely manner.
• Perform line clearances and line start verifications.
• Inspect products and documentation during and after production.
• Document inspection results and fill out reports.
• Help issue and organize production records and labels.
• Perform regular checks on product weights during production.
• Review in-process and completed batch records.
• Collect and store product samples.
• Assist with document control and compliance.
• Support other quality tasks as needed.