QC Microbiology Analyst

Proclinical; Norton (MA); On-site; GBP 42,000 - 47,000; Full time

Job summary

Proclinical is seeking a QC Microbiology Analyst on a contract basis in Norton, MA, to support quality control workflows in a pharmaceutical/biotech setting. The role requires performing microbiological testing, environmental monitoring, and ensuring regulatory compliance, with weekend shift availability.

The candidate should have GMP QC experience, knowledge of transfer and lifecycle management, and strong data analysis and technical writing skills.

Qualifications

• 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.

Responsibilities

• Conduct microbiological assays for raw materials, in-process samples, product release, and stability studies following 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.

Skills

GMP knowledge

Data analysis

Laboratory skills

Technical writing

Education

Chemistry/Biology/Biochemistry degree

Tools

LabWare

Excel

Word

PowerPoint

Job description

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.

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