Quality Control Microbiology Associate I

Position Overview:

We are seeking a dedicated and detail-oriented Quality Control Microbiology Associate I to join our team at our Norwood, MA manufacturing facilities. In this critical role, you will perform routine environmental monitoring and critical utility (WFI and Gas) sampling in support of both clinical and commercial manufacturing operations. This position is designed for individuals with a strong commitment to quality and a desire to contribute to a rapidly evolving, high-impact company.

Key Responsibilities:

• Conduct routine environmental monitoring (including In-Process and EMPQs), WFI sampling, and compressed gas sampling.
• Perform maintenance on lab equipment and support general housekeeping duties.
• Draft, revise, and adhere to standard operating procedures (SOPs), protocols, and reports.
• Ensure accurate data entry, review, and trending using LIMS (Laboratory Information Management System).
• Coordinate sample testing with internal and external laboratories.
• Troubleshoot equipment and testing methods to ensure consistent results.
• Support quality systems by documenting deviations, change controls, and corrective actions (CAPAs).
• Participate in audits and continuous improvement initiatives.

Basic Qualifications:

• Education: A degree in a relevant field (STEM focus preferred).
• Experience: A STEM degree with 0+ years of experience in a GMP-compliant QC laboratory setting, with a focus on microbiology.

Preferred Qualifications:

• Hands-on experience with particle counters, viable air samplers, and gas equipment.
• Proficiency in Microsoft Office Suite and electronic databases (LIMS, SAP, eQMS).
• Strong troubleshooting skills and the ability to effectively communicate scientific issues.
• Excellent written and oral communication skills, with a strong attention to detail and organizational capabilities.
• Solid understanding of GMP, microbiology, aseptic techniques, and laboratory instrumentation.
• Ability to work effectively in a fast-paced, cross-functional, matrixed environment.
• Familiarity with FDA, EU, ICH guidelines and regulatory requirements.
• A proactive, solution-oriented mindset with a passion for contributing to a high-growth, transformative company.

Shift Schedule:

• One position will be for Sunday to Wednesday, 1st shift.
• One position will be for Sunday to Wednesday, 2nd shift.
• One position will be for Wednesday to Saturday, 1st shift.
• One position will be for Wednesday to Saturday, 2nd shift.