Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Job Title: QC Manager

When you're part of Thermo Fisher Scientific, you'll do exciting work, and be part of a team that values performance, quality and innovation. As part of successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 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.

Working within our Microbiology Division (MBD), within the Specialty Diagnostics Group, you'll play an active part in helping us to achieve our mission. The Microbiology Division discovers microbiological solutions for the diagnosis of infectious disease and detection of bacterial contamination. We serve public health, clinical laboratories, food companies, environmental screening, and pharmaceutical laboratories with a portfolio of products that include culture media, antimicrobial susceptibility testing solutions and outstanding molecular solutions for food safety testing.

• 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.
• 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.
• Coordinate work scheduling, planning, and general administration of the Quality Control laboratory to ensure targets are met within agreed timeframes.
• Co-operate and provide leadership and guidance also to other business units, when needed.
• Ensure testing is carried out in accordance with product specifications and external quality control requirements.
• Monitor, record, analyze and report on activities, trends, results and recommendations relating to Quality Control and department activities
• Be responsible for the review and approval of all testing, reports, deviations, and department Standard Operating Procedures (SOP) to support the QC department.
• Maintain up to date knowledge of ISO, BS and other relevant standards and ensure their application in laboratory procedures.
• 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
• 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
• Provide microbiological technical expertise, trouble-shooting, training and support to the laboratory team in the testing of all product ranges
• Responsibility for the release of product to external and internal acceptance criteria
• 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
• Drive collaborative relationships between internal collaborator departments and Quality with the overall focus of improving customer satisfaction.
• Manage the personnel and fiscal budgets
• Supports, adopts and promotes the Thermo Fisher 4 I valves - Integrity, Intensity, Innovation and Involvement.

• Bachelor's degree required in the microbiology or sciences with experience in a medical device, pharmaceutical or clinical Quality Control.
• Experience leading a team of Scientists
• Experience running BSL2 laboratory, BSL3 experience preferred
• Experience with medical device, GMP, EU Regulation or ISO 13485, 11133, and Guide 34.
• Proven solid understanding of quality and scientific principles.
• Laboratory Safety Experience
• Ability to prioritize multiple tasks/functions optimally in a global organization.
• Proven track record to work effectively as a member of a cross-functional team.

• SAP Quality Module experience
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Excellent oral and written communication skills.