QC Analyst working shiftsEast Midlands Salary up to £25000 (dependant upon experience) + shift allowance (dependant upon the shift).Permanent Full TimeDo you have analytical experience...
Senior QC Analyst - Biologics
Competitive Salary + Excellent Benefits
Based in London
Do you have experience of Quality Control of manufactured Biomolecules such as proteins, antibodies or DNA?
Would you like to work for an award-winning and established Biotechnology company?
My client has established a high-quality manufacturing platform using novel in-vitro processes. Owing to their continued growth and success an exciting opportunity has arisen in the Contract Manufacturing Division for a Senior Quality Control Analyst.
The role is extremely broad, from establishing the QC function within this young company, testing raw materials, intermediates and products, managing stability programmes, interacting with suppliers and customers, working to improve QC systems and assuring cGMP compliance. This is a key role, working alongside the QA and Manufacturing Heads, and therefore comes with a significant level of responsibility. The role has substantial scope to expand into a management position as the company expands its team.
Duties will include:
- Take responsibility for the QC function in this growing CMO
- Perform analysis and report results in accordance with cGMP requirements for laboratory operations.
- Transfer analytical methods from the development team.
- Investigate analytical deviations and out of specification results with appropriate rigour and to contribute to their root cause resolution using a CAPA based system.
- Organise calibration and maintenance of analytical equipment.
- Conduct quality control testing of approved materials and end product, including approval or rejection according to protocols and specifications
- Support technical transfers between internal and external customers.
- Conduct method and equipment validation programs.
- Manage cGMP stability programs.
- Characterise reference materials for use in cGMP analysis.
- Develop, evaluate and prepare analytical methods and SOPs as required.
- Ensure cGMP compliance of all QC activities
- Conduct batch record review where required
- Work on customer complaint investigations, carrying out root cause analysis when necessary
- Develop and approve material and product specifications
- Work to continuously improve the Quality Management System as it applies to QC
Essential qualifications and experience:
- Experience in a Senior Quality Control role, you must possess strong, diverse skills and have a flexible technical approach.
- Experience of working in relationship with manufacturing in a Good Manufacturing Practice (GMP) laboratory is essential, with a willingness to combine laboratory and office-based tasks.
- Desire to work towards becoming a QC Manager in charge of a small team
- Experience of analytical methods for Proteins and DNA; ELISAs, SDS-PAGE gels & Western blotting is essential, for quality control testing
- The ideal candidate will have a Degree level qualification in Molecular Biology / Microbiology/ Biochemistry or a related discipline with relevant work experience in a controlled scientific environment.
- A broad range of laboratory skills is essential
- Reliable, enthusiastic and self-motivated as well as having excellent communication skills. Strong IT skills and experience of completing documentation with a high degree of accuracy is also a must.
This is an exciting opportunity to join a young,dynamic biotech company working at the forefront of biomolecule manufacture. In addition to receiving a competitive salary and performance related bonuses, the successful candidate will be invited to join the company pension scheme.
Please apply online or call Neil Walton on 02030964706
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.