Work Schedule

Flex 12 hr shift/days

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
• Cold Room/Freezers -22 degrees F/-6 degrees C
• Fluctuating Temps hot/cold
• Loud Noises (Equipment/Machinery)
• No contact lens allowed; prescriptive glasses will be provided
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Standing for full shift

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging work with a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. The company has a broad range employee benefits scheme that you can tailor to your preference.

Position Summary

The QA Operations Shift Lead role ensures the QA Operations team operate effectively to deliver quality on the floor and document review programs through direct and supervisory management. The role requires close collaboration across departments to ensure effective communication and early resolution of potential issues. The role is a hands-on shift based (24/7) to ensure all manufacturing operations have suitable QA Operations oversight with the responsibility to ensure GMP compliance is maintained. The establishment, maintenance and reporting of appropriate quality metrics (RFT, OTD, etc.) aligned to corporate goals for the QA Operations department is a fundamental part of the role.

Shift Pattern: 12 hour shifts (7am-7pm / 7pm-7am), 4 days on, 4 days off, 4 nights on, 4 days off.

Responsibilities

• Ensures the document review processes are supervised to deliver documentation to agreed timelines and ensure timely batch release.
• Is responsible for the resolution of significant quality issues through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patient’s safety.
• Accountable for the timely review and approval of deviations/ out of specifications /out of trends, CAPA, effectiveness checks, change controls, technical transfers, batch records, QC records, (etc).
• Prepares QA Operations data for inclusion in internal and external client meetings.
• Participation and presentation of QA Operations data to internal and external clients.
• Facilitates content of and participates in Quality huddles.
• Provides QA Operations input to Annual Product Quality Reviews (PQRs/ APQRs) and Quality Agreements.
• Represents QA Operations in risk management/improvement initiatives.
• Identifies and recommends Quality improvements based on related trends from Quality systems. Represents QA Operations in risk management/improvement initiatives.
• Leads Quality continuous improvement initiatives and provides quality assessments on process improvement (PPI) activities such as Mini Transformations or Kaizens to maintain an effective Quality on the Floor support.
• Supports the generation of new and improvement of site policies and implementation of corporate procedures.
• Assists the delivery of projects. Works with management to resolve project issues and resource constraints within the team.
• Conducts internal audits and participates in client, corporate audits and regulatory authority inspections as required.
• Provides QA oversight of data integrity practices, ensuring records and electronic data are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available in line with site and regulatory expectations.
• Ensures effective QA shift handovers and timely escalation of emerging quality or compliance risks to appropriate site leadership, maintaining clear ownership and continuity of actions.
• Provides QA oversight and approval, as appropriate, for qualification and validation activities impacting GMP manufacturing operations, ensuring quality requirements are considered throughout the activity lifecycle.
• Maintains a state of inspection readiness within QA Operations by promoting strong documentation practices, supporting readiness activities and ensuring actions arising from audits and inspections are progressed to completion.
• Monitors team training and competency requirements, ensuring QA Operations personnel remain appropriately trained and qualified to perform assigned GMP responsibilities.