We have an exciting opportunity for a QC Analyst to work for our global pharmaceutical client based in Milton Keynes. The role is a full-time temporary contract role signed off until the end of December 2024 with a possible extension. You will be required to work 37.5 hours per week (Monday - Friday) and our client offers an hourly rate of up to £18ph depending on experience, plus 25 days holiday pro rata.
The QC Analyst will be enthusiastic and dedicated to:
- To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.
- Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference sera, toxins etc.
Key Accountabilities and Duties
- Expertise in Immunology techniques such as ELISA's, haemagglutination tests, antigen mass assay is essential.
- Biology/Microbiology method validation / improvements and test transfer between labs/sites.
- Production and Validation and of biomaterials used in in-process and final product testing.
- Understanding of microbiology techniques is beneficial.
- Support in change management for introduction of new / improved methods and validation of new equipment.
- Be able to produce technical documents such as protocols, testing and execution plans and final reports.
- Update SOP's and other GMP documents ensuring they are current and relevant.
- Ability to work on several projects simultaneously and be able to prioritise.
- Reporting and communication of results to stakeholders. Liaise with several departments - technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
- The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.
- Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
- Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.
- Interact closely with fellow scientists and global/regional colleagues within own and other departments.
- Work in a multi-disciplinary and international team and environment.
Other responsibilities
- Comply with Standard Operational Procedures (SOP's), GMP, ESH procedures and corporate policies and process improvements.
- Maintain all documentation and training records as per GMP requirements.
- To comply with company's health and safety practices and procedures.
- Ensure positive, timely and effective communication with team members and internal customers.
Person Specification
Knowledge
- Good understanding and working knowledge of GMP Quality Systems
- Technical expertise in ELISA's and other immunology techniques, including microbiology techniques.
Experience
- Minimum 3 years of experience with excellent understanding of testing within a laboratory environment
- Laboratory investigations
- Validation and method development
- Previous roles include interaction with other operations and technical roles
Skills & Abilities
- Proficient in use of Microsoft Office especially Excel and Word.
- Good Protocol and Report writing skills.
- Ability to troubleshoot to resolve issues
- Basic Statistical understanding Knowledge such as Minitab Statistical software
Personal Attributes
- Ideal candidate should be self-motivated, hardworking, be able to work under pressure to deliver success within set timelines and hold a positive mindset
- Excellent organisational and planning skills and a flexible approach to changing priorities
- Able to communicate concise technical information with clarity, at all levels and across all functions
- Able to assist in fact finding discussions
- Attention to detail
Qualifications
- Degree in Biology/Microbiology (possibly a phD )
Other Requirements
- Cross functional work experience
- Demonstrated scientific problem-solving capabilities
- Full UK driving license