2 days old

CAPA Compliance Specialist

Virginia, MN 55792
Location :
US - Virginia - Middletown
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.

Thermo Fisher Scientific (NYSE: TMO) is headquartered in Waltham, MA, and is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual sales of more than $9 billion, we employ 30,000 people and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. Visit http://www.thermofisher.com.

Position Summary:

  • Provides overall management of the IR and/or CAPA process for the site. Leads the CAPA review activities.
  • Responsible for implementing and maintaining the effectiveness of the IR and CAPA elements of the quality system.
    • Support the site maintain compliance and complete IRs and CAPAs timely and effectively.
  • Ensures systems are established, effective and maintained in compliance with regulatory, corporate and site requirements and policies related to IRs and CAPA
  • Identifies, leads and implements initiatives for the continual improvement of the IR and CAPA processes.
  • Develops, implements, monitors and maintains meaningful metrics to demonstrate the effectiveness of the IR and CAPA processes.
  • Prepares audit responses and monitors and reports status of audit response progress to management.
  • Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations
  • Support, and hosts audit team for on-site inspections and audits by customers, and regulatory agencies.
  • Report metrics and provide input to management reviews where IR and CAPA issues are discussed advising management of potential risks and make recommendations.
  • Leads and/or assists with root cause analysis site program.
  • Minimal travel – approximately 20%

Minimum Requirements/Qualifications:
  • B.A., B.S. or M.S. in Life Sciences or an engineering discipline or an equivalent combination of education, experience and/or licensure/certification.
  • Prior experience in a leadership capacity preferred
  • The required skills, knowledge and abilities that are typically acquired through a minimum of 5 years medical device, pharmaceutical or food industry experience in quality assurance.
  • Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
  • Must have experience and knowledge of ISO 13485, 21 CFR Part 820, IVD Directive and Canadian MDR.
  • Communicate effectively both verbally and written with supplier and internal personnel in a professional manner. Strong writing and facilitation skills. Function with little to no supervision.
  • Demonstrated ability to work effectively in teams.
  • Detail oriented and has the ability to lead multiple projects and activities assigned.
Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.

Physical Requirements:

  • Normal office 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.

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.

Apply today! http://jobs.thermofisher.com

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here 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.


Posted: 2019-06-12 Expires: 2019-07-12

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CAPA Compliance Specialist

Virginia, MN 55792

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