QA Ops-Deviation Specialist
Company: Thermo Fisher Scientific
Posted on: November 19, 2021
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)
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.
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
Participate and drive towards organizational and site goals
Proactively identify and mitigate risks to ensure continuous
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
Solid understanding of US, EU and ROW cGMP guidelines and
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
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
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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