Senior QC Microbiologist
3 weeks ago
Cowley, United Kingdom
OXB
Full time
About the RoleOxford Biomedica is seeking a highly skilled Senior QC Microbiologist to join our team. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality and integrity in our manufacturing processes.
Key Responsibilities- Supervise and support a team of microbiologists to ensure the quality and integrity of our products.
- Plan, organize, and perform testing of raw materials, in-process, intermediates, and final product samples to ensure compliance with regulatory requirements.
- Maintain accurate and detailed records of microbiological test data.
- Ensure the microbiology laboratory is maintained to GMP standard and equipment is calibrated, maintained, cleaned, and monitored appropriately.
- Develop and review SOPs, protocols, and reports to ensure compliance with regulatory requirements.
- Communicate and initiate deviations or out-of-specification (OOS) results to manufacturing and other relevant departments to ensure timely corrective actions.
- Represent the microbiology laboratory in communications with manufacturing and supply chain to synchronize microbial testing as needed.
- Degree in Microbiology or other Life Science, or significant supplementing industry GMP QC Microbiology experience.
- Excellent knowledge of cGMP requirements, with a focus on documentation and laboratory activities to ensure compliance.
- Good understanding and knowledge of practical and theoretical microbiology techniques and aseptic techniques to enable effective and accurate environmental monitoring and microbial testing.
- Thorough understanding of GMP and cleanroom biocontamination control.
- Relevant experience in microbiology laboratory and GMP/clean rooms.
- Monitoring regulatory/industry updates.
- Experience in bioburden testing, environmental monitoring, endotoxin testing, sterility testing, media qualifications, and growth promotion testing.
- Working within ISO 8 to ISO 5 clean rooms and experience within aseptic fill finish activities.
Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world. We collaborate with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), and adenoviral vectors.
What We Offer- Highly competitive total reward packages.
- Wellbeing programmes.
- Development opportunities.
- Welcoming, friendly, supportive colleagues.
- A diverse and inclusive working environment.
- Our values are: Responsible, Responsive, Resilient, Respect.
- State-of-the-art laboratory and manufacturing facilities.