QC Microbiology Analyst

Proclinical Staffing; Norton (MA); On-site; USD 55,000 - 62,000; Full time

Job summary

Proclinical is seeking a QC Microbiologist to support quality control operations within a pharmaceutical or biotechnology environment. The role requires performing microbiological testing, environmental monitoring, and contributing to regulatory compliance.

Weekend shift availability is required to support operations and maintain quality standards. Responsibilities include raw material, in-process, and product release testing, bioburden and endotoxin analyses, documentation, and continuous

Qualifications

• Bachelor's or higher in chemistry, biology, biochemistry, or related field.
• Experience in GMP QC in pharma/biotech.
• Familiarity with method transfer, lifecycle management preferred.
• Strong writing, data analysis, problem-solving, and organizational skills.

Responsibilities

• Perform microbiological assays for raw materials, in-process samples, product release and stability studies.
• Carry out Bioburden, Endotoxin, and Biotoxin testing.
• Conduct environmental monitoring and maintain aseptic technique.
• Support weekend lab operations and training records.
• Assist with lab equipment maintenance, inventory, and reagents preparation.
• Review data as a qualified data reviewer and ensure SOP compliance.
• Contribute to updating SOPs, work instructions and test methods.
• Support regulatory submissions, inspections, and audits.

Skills

GMP QC experience

Data analysis

Technical writing

Problem solving

Organization

Collaboration

Weekend shift availability

Education

Chemistry/ Biology/ Biochemistry related field

Tools

LabWare LIMS

MS Office (Excel, Word, PowerPoint)

Job description

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.

Primary Responsibilities:

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.

Skills & Requirements:

• 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 LabWare, 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.

The QC Microbiology Analyst's responsibilities will be:

• 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.

Compensation:

• $40 to $45 per hour

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