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