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Thermo Fisher Scientific QA Operations Supervisor in Cambridge, Massachusetts

How will you make an impact?

Leads and supervises site Q-OPS related programs and activities to support the contract manufacturing organization and manufacturing operations. This role oversees Quality on the Floor, Batch Record Generation, Review, and Approval. Provides leadership, strategic thinking, and results focus to reliably meet and/or exceed the site's production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. Ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

What will you do?

  • Actively participates as a member of the Quality Ops Leadership Team and partners with the Operations management.

  • Support Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.

  • Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports.

  • Partner with functional leaders to identify key performance metrics and develop a plan for routine measurement.

  • Manage problems of diverse scope using a high degree of judgment and risk-based decision making

  • Apprise senior management of critical issues.

  • Champion process improvement concepts.

  • Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.

  • Support a state of continuous inspection readiness

  • Promotes Thermo Fisher's quality mission, vision and strategy

  • Ability to write reports, business correspondence and procedure manuals

  • Strong organizational skills; ability to prioritize and manage through complex processes/projects

  • Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

  • Ability to define problems, collect data, establish facts and draw valid conclusion

How will you get there?

EDUCATION:

  • Bachelors in Biological Science or related technical field.

  • At least 5-8 years of related experience in the Quality Unit.

  • Extensive exposure to cGMP environment.

  • Excellent communication skills

  • Ability to multitask, strategically and tactically

  • Excellent knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.

  • Ability to apply GMP regulations and international guidelines to all aspects of the position

  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

  • Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing - writing,

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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