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Thermo Fisher Scientific Quality Specialist II in Cambridge, Massachusetts

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

How will you make an impact?

The Quality Assurance Specialist II will support the quality systems team in Cambridge, MA. The Specialist will be responsible for evaluating, reviewing, and approving investigations and creating and monitoring the associated CAPAs or Change Controls. In this role, they will support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.

What will you do?

  • Supports the review and performance of investigations

  • Partners with the investigation team on definition and alignment of the investigation plan, required data, and timing for completion

  • Assist in deviation/nonconformance identification and resolution and will act as team member to investigate deviations to determine appropriate root cause and CAPAs.

  • Conduct QA assessments of product specific change controls, deviations, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker

  • Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations

  • Work with functional groups across the site to review and approve quality and technical documentation including: deviations, CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation.

  • Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities

  • May perform archiving duties in support of QA Document Control

How will you get here?

Education, Experience

  • Bachelor's degree and 3 years of related work experience or Master's degree and 1 year of work experience.

  • Preferred experience working in 2 or more functional areas

  • Minimum of 2 years in cGMP Quality Control operations in a fast-paced production environment

Knowledge, Skills, Abilities

  • Demonstrated ability collaborate across the business.

  • Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.

  • Demonstrated ability to present ideas persuasively and negotiate effectively

  • Excellent written and oral communication skills both internal and external.

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 .

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

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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