QC Microbiology Analyst

QC Microbiology Analyst
- Contract
- Norton, MA

Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of innovation and make a difference!

Proclinical is seeking a QC Microbiologist to support quality control operations within a pharmaceutical or biotechnology environment.

In this role, you will perform microbiological testing, environmental monitoring, and contribute to maintaining compliance with regulatory standards. This position requires attention to detail, strong technical skills, and the ability to work collaboratively in a fast-paced setting. Weekend shift availability is required.

• Educational background in chemistry, biology, biochemistry, or a related field.
• Experience in a GMP QC environment within the pharmaceutical or biotech industry.
• Familiarity with method transfer, implementation, and lifecycle management is preferred.
• Strong skills in technical writing, data analysis, problem-solving, and organization.
• Experience with Laboratory Information Management Systems (LIMS), particularly Lab Ware, is advantageous.
• Proficiency in Microsoft Excel, Word, and PowerPoint is preferred.
• Prior experience with bulk and in-process release testing and method transfers is beneficial.
• Availability to work a weekend shift.

• Conduct microbiological assays for raw materials, in-process samples, product release, and stability studies following standard operating procedures (SOPs).
• Perform Bioburden, Endotoxin, and Biotoxin testing.
• Carry out environmental monitoring and adhere to aseptic techniques.
• Support weekend lab operations and maintain accurate training records.
• Assist with lab equipment maintenance, inventory management, and preparation of reagents and samples.
• Review data promptly and act as a qualified data reviewer.
• Execute operational tasks such as raw material processes, environmental monitoring, and in-process testing.
• Contribute to updating controlled documents, including SOPs, work instructions, and test methods.
• Ensure compliance with internal policies, SOPs, and regulatory standards (GMP, GLP, ICH).
• Participate in continuous improvement initiatives and collaborate across functions.
• Support regulatory submissions, inspection readiness, and audits.

• $40 to $45 per hour