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Manufacturing Compliance Specialist - 2nd shift

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

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 Manufacturing Compliance Engineer will focus on Right First Time (RFT) initiatives

  • Review of manufacturing documentation for compliance to GDP and CPP prior to submission to QA
  • Provide on the floor document review, track and trend RFT metrics,
  • Evaluate trend data for process improvement
  • Deliver training to manufacturing teams on SOP/Process changes
  • Execute document and process improvement changes
  • Track training to maintain compliance

 

Responsibilities:

  • Support Right First Time initiatives as assigned
  • Perform review of Manufacturing Documentation across multiple production lines
    • Ensure all Manufacturing Documents are fully reviewed before submission to the Batch Release Group
    • Provide on the floor document review and recommendations for error corrections
  • Support manufacturing teams to provide feedback on error trends and area of focus
    • Record and maintain data to track batch record turnaround time, errors and document related deviations
    • Track training activities and curriculums to ensure compliance is consistently maintained
  • Partner with Training, Industrialization, Engineering and Manufacturing departments to provide detailed training on SOP and process changes to ensure compliance
    • Provide improvement ideas on documentation and processes
    • Complete change control to ensure that improvement ideas are fully implemented.
  • Partner with the investigation team to promote timely correction and closure of Non-Conformances
  • Perform any additional job related duties as requested

 

Studies and Experience:

  • Regulated industry environment experience 

  • HS diploma/GED and a minimum of 4 years experience required 

    • Associate degree (or higher) & 2 years experience preferred

  • Experience in FDA regulated environment with knowledge of Good Manufacturing Practices preferred

  • Experience in Batch Record review preferred

  • Experience in delivering training preferred

 

Skills and Qualifications:

  • Knowledge of Microsoft Word, Excel, PowerPoint and Outlook required.
  • SAP experience preferred
  • Quality documentation review in production facility preferred Excellent interpersonal skills and ability to work with all levels of an organization
  • Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
  • Must be able to work effectively in a team based and individual environment.
  • Must hold to the highest level of accountability and integrity
  • Must be able to deliver negative and positive feedback effectively.
  • Leadership experience preferred
  • Strong analytical and problem-solving skills.
  • Ability to translate written instructions, work orders and specifications.

 

Physical Requirements:

  • Ability to regularly climb stairs to perform work
  • Ability to work overtime as required to support a 24/7 production operation
  • May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials
  • May be exposed to strong odors incurred during media production or other operations 
  • May be required to wear various types of PPE & cGMP which includes but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats.

 

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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