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 -22degreesF/-6degrees 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.
People Management
- To create successful work environments and provide support & guidance to your teams ensuring high levels of performance.
- To complete People Management tasks for your team including:
- Selection and development of QA Operations staff to deliver the Quality on the Floor program and ensure a proactive approach to Quality.
- Onboarding and training
- Setting clear goals and performance expectations
- Providing open and timely feedback.
EH&S:
- Ensure their own and teams compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure their own and teams timely reporting and investigation of all accidents, near misses and breaches of rules.
- Understand and ensure implementation of emergency procedures and safe systems of work.
Minimum Requirements/Qualifications:
- Minimum Science based degree
- Substantial experience, minimum 5 years’ working in or directly supporting manufacturing within a drug product manufacturing site. Sterile experience is preferred.
- Experience of leading, supervising and motivating a team.
- Strong leadership skills with excellent collaboration, communication, and problem-solving skills.
- Ability to apply their strong working knowledge of the principles and guidelines for cGMP as set out in the Eudralex Volume 4 and U.S. 21CFR part 210/211
- Is not afraid to make decisions with demonstrated experience of the appropriate application of Quality Risk Management principles. Holds self and others accountable in achieving goals.
- Excellent written and verbal communication skills to internal and external customers
- Ability to work in a fast paced, matrix environment and capability to work to timelines and prioritize multiple tasks is vital.
- Flexibility to meet changing needs and priorities of the business is crucial.
- Experience in leading change and delivering continuous improvement is desirable.
- Experience of developing and influencing business strategy and a proactive quality culture is desirable.
What’s in it for you:
Competitive base salary, Annual bonus, Free on-site car parking, Contributory Pension, Private medical insurance and Flexible benefits.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.