Work Location:

Middlesex County, Massachusetts

Summary:

Seeking a QC Microbiology Analyst for a contract-to-hire role focused on supporting microbial quality control testing, quality assurance documentation, and continuous improvement initiatives in a GMP manufacturing environment. This position requires a strong quality mindset and hands-on microbiology bench skills.

Responsibilities:

• Maintain and support quality systems in compliance with cGMP, FDA, and ISO regulations within the microbiology laboratory.
• Perform and document routine and non-routine microbial testing, including environmental monitoring, bioburden, endotoxin, and sterility testing.
• Author, review, and revise SOPs, work instructions, and controlled documentation related to laboratory operations.
• Participate in deviation investigations, root cause analysis, and CAPA implementation for microbiology-related events.
• Review and approve QC microbiology data to ensure accuracy, completeness, and compliance with data integrity requirements.
• Operate and maintain laboratory equipment, perform cleanroom gowning, and work within classified environments as required.
• Identify and implement laboratory process improvements using 5S methodologies and lean principles.
• Collaborate with cross-functional teams to support product quality, process optimization, and audit readiness activities.

Qualifications:

• Bachelor's degree in Microbiology, Biology, or a related life sciences discipline.
• 2+ years of hands-on experience in QC microbiology within a GMP pharmaceutical, biotech, or medical device manufacturing environment.
• Experience with environmental monitoring programs, water testing, bioburden, endotoxin, and/or sterility testing.
• Working knowledge of cGMP regulations, FDA guidance, and data integrity principles.
• Experience with deviation investigations, CAPA processes, and quality documentation (SOPs, protocols, reports).
• Proficiency in aseptic technique and experience working in cleanroom environments.
• Strong attention to detail with a quality-first mindset.
• Familiarity with in-process inspection of aseptic fill operations and media cassette production is a plus.
• Experience using Smartsheet, LIMS, or similar tools for quality data tracking and trending is preferred.
• Exposure to 5S, lean manufacturing, or other continuous improvement frameworks within a laboratory setting is advantageous.

Published Category:

Quality & Validation