Operations Compliance Specialist
Thermo Fisher Scientific

Job Info

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Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Operations Compliance Specialist

When you join Thermo Fisher Scientific, you'll have the opportunity to make a real-world impact by supporting our mission to enable our customers to make the world healthier, cleaner, and safer. As an Operations Compliance Specialist, you'll play a vital role in ensuring that our manufacturing operations are maintained to the highest standards, allowing us to continue making a difference.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

As an Operations Compliance Specialist, you will have the important responsibility of ensuring that our facility operates in an audit-ready state at all times. By maintaining compliance with industry regulations, you will help us maintain our manufacturing license, allowing us to continue delivering exceptional products and services to our customers.

What will you do?

• Conduct daily compliance walkthroughs, meticulously checking items such as fit and finish, up-to-date logbooks, correct execution of aseptic practices, acceptable cleaning standards, accurate material labeling, and no expired items.
• Collaborate with area leadership to identify and close any compliance gaps.
• Take immediate action to remediate any compliance gaps that are discovered.
• Provide training and support to employees ensuring adherence to established procedures and guidelines.
• Place work orders as necessary to address compliance issues.
• Contribute to the identification of process improvement opportunities and support the implementation of corrective actions regarding compliance.

How will you get here?

• Bachelor's degree preferred
• 2+ years of experience, preferably in a cGMP environment

Knowledge, Skills, Abilities

• Strong understanding of production processes and the biopharma production environment.
• Excellent knowledge of cGMP and other regulatory requirements related to cleanroom operations.
• Familiarity with cGMP quality systems, including change control, deviations, investigations, risk assessments, and ensuring good documentation practices.
• Proactively takes initiative and consistently achieves desired outcomes.
• Exceptional problem-solving skills.
• Highly organized, efficient, and focused on achieving results.
• Proficient in Microsoft Office tools, including report writing and graphing.

At Thermo Fisher Scientific, we value the unique stories and perspectives of each of our 70,000 extraordinary minds. Join us and contribute to our ambitious mission of making the world healthier, cleaner, and safer.

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