Overview
Join to apply for the QA officer role at Thermo Fisher Scientific.
Work Schedule: 12 hr shift/nights.
Environmental Conditions: Cleanroom – restrictions include no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.; Office.
Position Summary: Thermo Fisher Scientific Inc. offers a groundbreaking chance to join a top-tier team in Swindon, UK. As a key part of our Manufacturing team, you will be involved in setting up and running our powerful facility. This hands-on role is essential for ensuring high-quality production, identifying and solving issues promptly to support efficient manufacturing operations.
Responsibilities
* Offer quality assurance supervision for operational tasks within the designated team.
* Review sterilization cycles, FMS systems, and other key controls of clean rooms.
* Manage logbooks and support area controls.
* Perform online review of batch records.
* Close batch records with associates LIMS & SAP transactions and C of A generation.
* Review and update Standard Operating Procedures and Controlled Documents.
* Direct clean rooms and support zones; ensure behavior and conformity to SOPs, including entering clean rooms physically and keeping up with at least an L1 license.
* Direct the packaging departments; uphold conduct standards and adherence to SOPs.
* Actively produce and promptly assess minor DRs & CAPA with cell members.
* Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members.
* Conduct local area and local system audits.
* Train and mentor Operations staff and QA peers.
* Communicate effectively, attend Tier 1 meetings, and participate in planning and problem-solving activities.
* Offer re-validation resources to the aligned cell effectively.
* Observe, incubate, read, and write reports for media fills.
* Conduct clean room physical checks – velocities, air patterns, DOP tests, and particle counting.
* Perform autoclave load pattern re-qualification.
* Test sterilizing filters.
* Validate cleaning processes.
* Conduct AQL-based visual inspection.
Experience / Qualifications:
* Preferred relevant science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy.
* Proven experience in the pharmaceutical industry, preferably in sterile product manufacture.
* In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing.
* Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization.
* Proactive approach to continuous improvement and project work.
Our package includes a variety of adaptable benefits like Pension and Healthcare, along with competitive pay. Join our enthusiastic team working towards making a tangible difference in the world!
Seniority level: Not Applicable
Employment type: Full-time
Job function: Quality Assurance, Product Management, and Engineering
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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