Thermo Fisher Scientific Quality Control Auditor in Middletown, Virginia

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

Quality Assurance Auditors are responsible for implementing and maintaining the effectiveness of the Quality System.

What will you do?

  • Perform product audits via documentation through batch record review of raw materials, components, bulks, and kits.

  • Prioritize work based on ship dates, backorders, and projects.

  • Review, maintain and provide, as requested, documents and records to satisfy international regulatory requirements.

  • Assemble documentation requested for product registrations, failure investigations, and other regulatory requirements.

  • Maintain lot history files of batch records for each product released from this operation. This includes filing, retrieving, and cataloging.

  • Assist the management team and staff members with revision of departmental processes to ensure continual improvement.

  • Assist the SAP Coordinators when needed by performing necessary MRP/SAP system task activities as part of batch record reviews.

  • Alternate work schedule and extended hours will be required to support changes in manufacturing schedule and the need to meet customer expectations on delivery times. Weekend work will be required but minimized as much as possible.

  • Perform other duties as assigned.

How will you get there?

  • High School graduate or equivalent with a minimum of 3-5 years’ experience in Quality Assurance or Quality Control; BS or BA from an accredited college or university with 5 years of QA/QC experience preferred. Prior manufacturing experience is preferred.

  • Working knowledge of QSR/GMP/GLP regulations, ISO Standards, safety policies and procedures.

  • Working knowledge of the metric system with a focus on weights and volumes. Able to follow/monitor math calculations.

  • Communicate effectively both verbally and written with personnel at all levels in a professional manner.

  • Function in a team environment and receive direction and guidance primarily from peers with minimal supervision from management.

  • Detail oriented with the ability to coordinate multiple activities at once.

  • Troubleshooting and problem solving skills

  • Working knowledge of MS Office (Outlook, Excel, Word); SAP experience desired.

Physical Requirements:

  • Normal laboratory/manufacturing environment.

  • Position may require frequent communication and walking to other areas in which designated PPE will be required.

  • Position will require sitting and standing.

  • Employee may occasionally lift and/or move up to 10 pounds.

This position is not approved for relocation benefits.

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.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.