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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Title:** **_Quality Specialist Lead_

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Thermo Fisher Scientific, Viral Vector Services (VVS) is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve.

How will you make an impact?

Thermo Fisher Scientific, VVS division, is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. The Quality Assurance Specialist Lead 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?

+ Lead/Supports deviation process, investigations and closure while participating in cross functional project teams

+ Conduct QA assessments for change controls, deviations, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision makers

+ Act as the site experts on Global TrackWise for deviation, CAPA, and change control

+ Represent site while working with global quality management system teams, support gap assessment and lead site inspection readiness program

+ 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 on 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.

+ 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

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

How will you get here?

+ Bachelor’s degree in science related discipline is required

+ Preferred experience working in 2 or more functional areas

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.

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.

Apply today! http://jobs.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 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.