QA Officer (GMP Environment)

Job description

Work Schedule Rotational shift nights/weekends Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse Job Description Working shift pattern: 4 days on ; 4 days off - Day & Night shifts As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As a member of our Quality Assurance team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines. Thermo Fisher Scientific Inc. offers an exciting opportunity to join a top-tier Manufacturing team at our Swindon, UK site , a leading facility specializing in sterile pharmaceutical production , including liquids and lyophilized products for clinical and commercial use. The Swindon site features state-of-the-art filling lines, lyophilizers, and advanced packaging capabilities , and is fully compliant with international regulatory standards such as MHRA and FDA . As part of our global network, the site plays a critical role in delivering vaccines and life-saving therapies to patients worldwide . This is a hands-on, high-impact role for candidates with at least 3 years of experience in sterile manufacturing or a related pharmaceutical environment. You will ensure high-quality production , proactively identify and resolve operational issues , and help drive continuous improvement in a fast-paced, innovative setting. Responsibilities: Provide quality assurance oversight for operational tasks within the assigned team. Review sterilization cycles, FMS systems, and other key cleanroom controls. Manage logbooks and support area control compliance. Perform online batch record review and close batches with LIMS & SAP transactions and C of A generation. Review, update, and maintain Standard Operating Procedures and Controlled Documents. Supervise clean rooms and support zones; ensure adherence to SOPs and maintain at least an L1 license. Direct packaging operations, enforcing conduct standards and SOP compliance. Proactively generate and assess minor DRs & CAPAs with cell members. Implement and evaluate level 0 & level 1 modification controls. Conduct local area and system audits. Train and mentor Operations staff and QA colleagues. Communicate effectively, attend Tier 1 meetings, and contribute to planning and problem-solving activities. Support re-validation activities for assigned production cells. Observe, incubate, read, and report on media fills. Perform cleanroom physical checks – velocities, air patterns, DOP tests, and particle counting. Re-qualify autoclave load patterns and test sterilizing filters. Validate cleaning processes Conduct AQL-based visual inspections. Experience / Qualifications: Minimum 3 years of experience in a QA position Previous experience in a sterile, aseptic pharmaceutical manufacturing or related controlled, GMP environments is essential Strong knowledge of cGMP and regulatory requirements for pharmaceutical production. Knowledge of sterilization processes, FMS systems, and other key cleanroom controls would be a strong advantage Experience with clean room operations and gowning procedures preferred Ability to understand and interpret technical procedures and specifications Proactive approach to continuous improvement, problem-solving, and project work. Excellent interpersonal skills with the confidence to challenge behaviors at all levels.