Quality Specialist II, QS

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital 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.

Discover Impactful Work:

The Quality Specialist II will report directly to the Head of Quality Systems. The position's focus is to ensure the compliance and continual improvement of key QMS elements including Deviations, Change Control, CAPA, OOS, and Quality Management review. This position also supports production partners as needed, to ensure on-time delivery to customers.

A day in the Life:

• Partners with functional areas to ensure Change Controls, Deviations, CAPAs, and OOS records are compliant and closed on time.

• Leads meetings related to change controls (CCRB), deviation triage and CAPA governance.

• Engaged partner with function areas in the determination of root cause and impact assessment.

• QA reviewer of quality system documents

• Interface between with site resources to implement key systems and maintain them in a state of compliance.

• Generate metrics and monitor Quality Systems used to drive improvement.

• Generate and deliver content to support implementation and sustaining Quality Management System.

Keys to Success:

Education

• Bachelor's degree, or an MS in chemical engineering, biochemistry, biology, or a related field required.

Experience

• Minimum of 2 years' experience in the pharmaceutical or biotech, or regulated industry, preferably with QA, QC or manufacturing experience.

• Familiarity with enterprise software systems including ERPs, electronic document control systems, Track wise and training software packages.

Knowledge, Skills, Abilities

• Strong critical thinking skills, with a close attention to detail and history of good judgment

• Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint)

• Shown ability to work in a team and matrixed environment

• Driven and resourceful, with minimal to moderate direction required

• Effective at work prioritization with strong time management skills

Physical Requirements / Work Environment

• Ability to gown into cleanroom environment.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

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