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QA Ops-Deviation Specialist

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: November 19, 2021

Job Description:

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
This position will be based at our Cambridge, MA site

Day Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 7AM-7PM

How will you make an impact?
The Quality Assurance Deviation Specialist II requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will provide quality oversight for documentation, investigations, and improvement initiatives within manufacturing operations.

Position Description/Summary:
The Deviation Specialist II is responsible for oversight and approval of deviations at the Cambridge facility. This role will partner with manufacturing for deviation generation, closure, and support of corrective and preventative actions.

Identify and support resolution of manufacturing deviations and drive continuous improvement in process operations.
Work collaboratively with manufacturing on the floor with closure of minor deviations
Provide support as needed for major deviations
Build cross functional relationships and enhance relationships with team members
Participate and drive towards organizational and site goals
Proactively identify and mitigate risks to ensure continuous improvement
Ensure all quality related activities are performed and achieve on-time completion of Quality deliverables
Resolve Quality related issues

How will you get here?
Bachelor's Degree in Sciences and minimum 3-5 years' Quality related experience
Solid understanding of US, EU and ROW cGMP guidelines and requirements.
Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
Ability to understand operational documents for GMP compliance, accuracy and completeness.
Ability to work by influencing a matrix management system and to gain the cooperation of others.
Strong time management and organizational skills.
Excellent written and oral communication skills both internal and external.
Able to manage multiple priorities and demonstrate self-control
Ability to resolve conflict within project teams.
Good leadership skills.
Strong attention to detail
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Ability to function in a rapidly changing environment & handle multiple priorities. A flexible work schedule is required. Ability to lift up to 25 lbs. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.

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, Cambridge , QA Ops-Deviation Specialist, Other , Cambridge, Massachusetts

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