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Associate Manager, Document Control - Durham

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

Position Summary:

The QA Change Control Associate Manager is responsible for the daily management of site change management activities, and for implementing continuous improvement activities associated with the Change Management process at the Durham site.

 

Primary Duties:

  • Manages and develops staff to ensure targeted department and site objectives are met 
  • Provide QA oversight and technical assistance to owning departments (e.g. Industrialization, Facilities, Manufacturing)
  • Chair the Change Control Review Board Meeting
  • Serve as SME on Durham Change Control Process and interface with customers and regulatory agencies for Inspections and Audits (MDSAP, FDA, ISO, Customer, etc)
  • Support QMS Activities by participating in cross functional projects/activities
  • Responsible for Doc. Control KPIs (ie., 3 yr Review, CR on-time) 
  • Implement Key Performance Indicators/metrics to track performance 
  • Implement continuous improvement programs/projects to improved compliance to regulatory and industry standards.
  • Serve as backup to Investigations Coordinator
  • Perform any additional job related duties as requested
  • Supplemental Data: Responsible for Managing a Team of 3 and occasionally an intern. Manage and key contact to Infolinx, TWD CR Platform. 

 

Training, Education, and Experience:

  • BA/BS Degree in a science related field preferred and a minimum five (5) years of experience working in an FDA regulated environment with knowledge of Good Manufacturing Practices required
  • No supervisory experience required, three (3) years supervisory or management experience preferred
  • Prior experience in quality management systems activities including conducting gap assessments and driving closure to achieve compliance with site and regulatory standards (ex: ISO 9001, ISO13485) preferred
  • Prior work history with Electronic Quality Management System (eQMS) Software solutions preferred
  • Demonstrated ability in providing compliant and practical solutions to complex quality issues preferred
  • Experience managing nonconformance quality system or Investigation writing experience preferred
  • Competence in the selection and use of Quality Engineering Tools and Techniques
  • Computer skills required, including TrackWise, TWD and Microsoft Office 

 

Knowledge, Skills, and Abilities:

  • Excellent interpersonal skills and ability to work with all levels of an organization 
  • Ability to work independently and in a team environment
  • Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment
  • Ability to work effectively and efficiently toward goal completion in a complex, diverse environment 
  • Ability to effectively communicate verbally and in writing; technical writing skills preferred 

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

 

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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