Quality Control Associate - Microbiology

Location: Waltham MA - Onsite 5 days

Position Summary The Quality Control Associate - Microbiology is responsible for supporting routine Quality Control Microbiology activities within a GMP-regulated manufacturing environment. This role plays a key part in ensuring laboratory and cleanroom operations are executed accurately, efficiently, and in compliance with applicable regulatory requirements. Responsibilities include environmental monitoring, microbiological testing, data entry and review, equipment maintenance, and support of quality systems activities.

Key Responsibilities

• Perform routine environmental monitoring, utility monitoring, and microbiological testing activities in accordance with cGMP regulations, internal procedures, and industry standards.

• Conduct standard QC microbiological assays, including:

• Bioburden Testing

• Endotoxin Testing

• Sterility Testing

• Growth Promotion Testing

• TOC/Conductivity Testing

• Additional microbiological analyses as required

• Review and verify assay results to ensure accuracy and compliance.

• Perform routine data entry, documentation, and record review within Laboratory Information Management Systems (LIMS).

• Execute environmental and utility monitoring activities in Grade A, B, C, and D cleanroom environments.

• Perform routine preventative maintenance and upkeep of QC Microbiology equipment.

• Support quality system processes, including:

• Laboratory Investigations

• Deviations

• Corrective and Preventive Actions (CAPAs)

• Change Controls

• Associated Quality Actions

• Maintain compliance with applicable SOPs, quality standards, and regulatory requirements.

• Collaborate effectively with cross-functional teams while independently managing routine responsibilities.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Engineering, or a related scientific discipline.
• 0–2 years of experience in a GMP-regulated Quality Control Microbiology laboratory environment.
• Strong organizational skills with exceptional attention to detail.
• Ability to follow and execute standard operating procedures (SOPs).
• Strong written and verbal communication skills.
• Ability to work both independently and within a collaborative team environment.

Preferred Qualifications

• Knowledge of GMP, GLP, quality systems, and laboratory compliance requirements.
• Familiarity with environmental monitoring programs and applicable USP, ISO, and EU GMP regulations.
• Experience in cell therapy, gene therapy, biotechnology, pharmaceutical, or related manufacturing environments.
• Experience with systems such as MODA, Veeva, Kneat, SAP, BMRAM, or similar platforms.

Physical Requirements

• Ability to lift and carry up to 20 pounds.
• Ability to stand and remain on feet for extended periods (up to 4 hours at a time).
• Ability to aseptically gown and work in cleanroom environments.
• Flexibility to support occasional off-shift hours as required for testing and operational needs.