:
1. Lead and develop staff within the function to a high level of competency and performance. Set clear, comprehensive expectations demonstrate role model leadership; provide meaningful, timely feedback about performance, train and coach to continuously improve individual performance and business results.
2. Empower staff to be innovative and involved, eliminate waste and address problems quickly and efficiently; always with a view toward meeting or exceeding customers’ expectations.
3. Coordinate work scheduling, planning, and general administration of the Quality Control laboratory to ensure targets are met within agreed timeframes.
4. Co-operate and provide leadership and guidance also to other business units, when needed.
5. Ensure testing is carried out in accordance with product specifications and external quality control requirements.
6. Monitor, record, analyze and report on activities, trends, results and recommendations relating to Quality Control and department activities
7. Be responsible for the review and approval of all testing, reports, deviations, and department Standard Operating Procedures (SOP) to support the QC department.
8. Maintain up to date knowledge of ISO, BS and other relevant standards and ensure their application in laboratory procedures.
9. Driving a culture of continuous improvement within the laboratory by ensuring process performance and compliance improvement programs for the Microbiology Laboratory are identified and implemented
10. Ensuring non-conformances impacting Microbiology Laboratory processes and initiated and investigated in a timely manner, collaboratively with the Manufacturing sciences team, to minimize in impact to the customer
11. Provide microbiological technical expertise, trouble-shooting, training and support to the laboratory team in the testing of all product ranges
12. Responsibility for the release of product to external and internal acceptance criteria
13. Maintain a safe laboratory work environment and follow all laboratory safety requirements, work with the Site and divisional health and safety team to ensure compliance with appropriate regulations
14. Drive collaborative relationships between internal collaborator departments and Quality with the overall focus of improving customer satisfaction.
15. Manage the personnel and fiscal budgets
16. Supports, adopts and promotes the Thermo Fisher 4 I valves – Integrity, Intensity, Innovation and Involvement.
Minimum Qualifications & Experience:
17. Bachelor’s degree required in the microbiology or sciences with experience in a medical device, pharmaceutical or clinical Quality Control.
18. Experience leading a team of Scientists
19. Experience running BSL2 laboratory, BSL3 experience preferred
20. Experience with medical device, GMP, EU Regulation or ISO 13485, 11133, and Guide 34.
21. Proven solid understanding of quality and scientific principles.
22. Laboratory Safety Experience
23. Ability to prioritize multiple tasks/functions optimally in a global organization.
24. Proven track record to work effectively as a member of a cross-functional team.
Preferred Qualifications & Experience:
25. SAP Quality Module experience
26. Strong leadership skills with the ability to challenge, influence, and build consensus.
27. Excellent oral and written communication skills.
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