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Supervisor, QA NTO

Company: Thermo Fisher Scientific Inc.
Location: Cambridge
Posted on: June 10, 2021

Job Description:

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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.

REPORTING RELATIONSHIPS Supervises: 4-5 direct reports

What will you do?

  • Actively participates as a member of the Quality Ops Leadership Team and partners with the Operations management.
  • Supports Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
  • Reviews and approves documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports.
  • Partners with functional leaders to identify key performance metrics and develops a plan for routine measurement.
  • Manages problems of diverse scope using a high degree of judgment and risk-based decision making
  • Apprises senior management of critical issues.
  • Champions process improvement concepts.
  • Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.
  • Supports a state of continuous inspection readiness
  • Promotes Brammer's quality mission, vision and strategy

ADDITIONAL DUTIES AND RESPONSIBILITIES

  • 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:

  • High school diploma with at least 5-8 years of related experience in the Quality Unit.
  • Preferred BS in Biological Science or related technical field.
  • 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

PHYSICAL DEMANDS:

  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing - writing,

This job description is not all inclusive, additional duties may be assigned.

At Thermo Fisher Scientific, each one of our 70,000 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.

Keywords: Thermo Fisher Scientific Inc., Cambridge , Supervisor, QA NTO, Other , Cambridge, Massachusetts

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