QC Microbiology Analyst

Primary Responsibilities

• 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.
• Affix 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 & 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

• Weekend shift availability is required.

Compensation

$40 to $45 per hour

Contact

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Application

If you are interested in applying to this exciting opportunity, then please click 'Apply'