Job Reference: J5635303
Updated On: 26/07/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a QC Specialist - Microbiology and Environmental Monitoring to join a leading Cell and Gene Therapy company based in the Hertfordshire area. As the QC Specialist you will be responsible for supporting the activities of the manufacturing centre GMP QC Laboratories and associated infrastructure.
Key Duties and ResponsibilitiesYour duties as the QC Specialist will be varied however the key duties and responsibilities are as follows:
1. As the QC Specialist you will act as the Subject Matter Expert for the Microbiology and Environmental Monitoring provision.
2. You will assist in the development of validation protocols and reports specifically associated with Microbiological testing .e.g bioburden assays
3. The QC Specialist will also be responsible for provide support to ensure teh QC group operates to a high standard and complies with cGMP and other appropriate regulatory standards/
4. You will generate, review and approve cGMP documentation such as SOPs whilst also being involved in Out of Tend, Out of Specification and Deviation management events associated with QC activity.
Role RequirementsTo be successful in your application to this exciting opportunity as the QC Specialist - Microbiology and Environmental Monitoring we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences or Microbiology related discipline plus industry experience.
2. Proven industry experience working in microbiology or an aseptic biopharmaceutical manufacturing environment.
3. A working knowledge and practical experience performing standard microbiological analytical techniques and writing/reviewing GMP documents.
Key Words: QC / Quality Control / Microbiology / Microbiologist / Specialist / Environmental Monitoring / Sterility / Aseptic / Endotoxin / Bioburden / Cell Therapy / Gene Therapy / Life Sciences / Biopharmaceutical / Manufacturing / cGMP / GMP / Good Manufacturing Practice.
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