Negotiable
Undetermined
Undetermined
Wrexham, Wales, United Kingdom
Summary: The QC Microbiologist role at Proclinical involves supporting environmental monitoring and microbiological testing within the biopharmaceutical industry. The position requires compliance with GLP, GMP, and regulatory standards while operating on a shift schedule. Key responsibilities include conducting tests on raw materials, in-process samples, and finished products, as well as maintaining laboratory compliance. The role also emphasizes training and process improvement initiatives.
Key Responsibilities:
- Conduct environmental monitoring of clean rooms and controlled environments.
- Perform microbiological testing of raw materials, in-process samples, and final products.
- Identify microbial isolates efficiently and accurately.
- Test and maintain culture media stocks.
- Manage laboratory stock levels and ensure equipment maintenance.
- Maintain laboratory areas in a compliant and inspection-ready state.
- Record and maintain QC microbiological data accurately.
- Identify and investigate out-of-specification results and unplanned events.
- Provide training on basic microbiological methodologies.
- Participate in validation studies and project work.
- Ensure compliance with GMP, safety, and regulatory requirements.
- Suggest process improvements and support new initiatives.
Key Skills:
- Proficiency in aseptic techniques and gowning.
- Knowledge of US/EU cGMPs and their application in biopharmaceutical testing.
- Experience in a microbiology laboratory or GMP production environment.
- Strong organizational and problem-solving skills.
- Ability to prioritize tasks and meet deadlines.
- Effective communication skills to present microbiological information clearly.
- Degree in a scientific discipline or equivalent experience (HND minimum).
- Familiarity with pharmacopoeia requirements and industry standards.
Salary (Rate): undetermined
City: Wrexham
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Biopharmaceuticals
Job Title: QC Microbiologist
Job Function: Quality Control Microbiology
Therapy Area/Industry: Biopharmaceuticals
Location: Wrexham
Job Description: Proclinical is seeking a QC Microbiologist to support environmental monitoring and microbiological testing of raw materials, in-process samples, and finished products. This role involves working in compliance with GLP, GMP, and regulatory standards. The position operates on a shift schedule (4 on, 4 off).
Responsibilities:
- Conduct environmental monitoring of clean rooms and controlled environments.
- Perform microbiological testing of raw materials, in-process samples, and final products.
- Identify microbial isolates efficiently and accurately.
- Test and maintain culture media stocks.
- Manage laboratory stock levels and ensure equipment maintenance.
- Maintain laboratory areas in a compliant and inspection-ready state.
- Record and maintain QC microbiological data accurately.
- Identify and investigate out-of-specification results and unplanned events.
- Provide training on basic microbiological methodologies.
- Participate in validation studies and project work.
- Ensure compliance with GMP, safety, and regulatory requirements.
- Suggest process improvements and support new initiatives.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.