Quality , Science, Pharmaceutical & Food
PE Global is currently recruiting for a QC Biologist for our leading multi-national client based in Milton Keynes, Buckinghamshire.
Purpose of Role
To support 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.
· 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.
· Good understanding and working knowledge of GMP Quality Systems
· Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.
· 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
· Degree in Biology/Microbiology
· Full UK driving licence
Interested candidates should submit an updated CV. Please click the link below to apply, call Miriam on 0044 203 868 9800 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***