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Thermo Fisher Scientific QA Specialist III 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 III will support the alignment to the global quality standards within the network. Develop strategies and translate these into realistic projects utilizing QA, QC, MST and Manufacturing resources. Coordinate investigations, CAPA generation, KPI development/reporting, status tracking, and system training for quality systems at the site.

What will you do?

  • Leads/supports deviation process, investigations and closure while participating in cross functional project teams

  • 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

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

  • Identifies and mitigates risks in quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product

  • 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.

  • Act as one of the site experts on Global TrackWise for deviation, CAPA, and change control

  • Sets performance objectives, development plans and monitors performance progress for the site on quality system performance. Analyze and trend all types of data (CAPA, deviations) to identify deficient areas and initiate quality improvement projects

  • Track and report on deviation, CAPA, and change control progression to ensure a well-managed program and timely close out

  • Lead efforts to establish and streamline the site change control process

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

How will you get here?

Education, Experience

  • Bachelor's degree and 4-5 years of related work experience or Master's degree and 1-3 years of work experience.

  • Preferred experience working in 2 or more functional areas

  • Minimum of 3 years in cGMP Quality Control operations in a fast-paced production environment

Knowledge, Skills, Abilities

  • Demonstrated ability to manage cross-functional teams and 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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