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Doc and Data Specialist

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Engineering

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 purpose of this job is to oversee the management of electronic and hardcopy documentation throughout a document’s lifecycle, monitors the status of corrective actions, including periodic procedural document reviews, intra-/extra-departmental audits or other and supports departmental projects as required.

 

Main Accountabilities:

  1. Generate, maintain, issue, and track all electronic and hard-copy controlled documents in accordance with company policies and regulatory agency (e.g., FDA and ISO) requirements
  2. Receive, review, process, and track all document change requests (CRs) in compliance with company policies. Maintain a CR tracking database to track CR turnaround time. 
  3. Manage waiver using Trackwise from initiation to closure, working cooperatively with owners to ensure completion within the timeframes specified .
  4. Maintain and review the training curriculum and serve as the coHRus administrator for all employees in the Industrialization department
  5. Perform set card/organism testing, experiments, data gathering experiments as needed to support departmental projects.
  6. Support departmental projects/experiments/validations as required.
  7. Expectation to have the capacity to understand all manufacturing specifications, documentation and manufacturing requirements, and procedures adequately to confirm conformance and to provide input regarding the continuous improvement of each. In addition, the ability to function in a structured/organized manner, and the ability to follow through on given tasks

 

Studies, Experience, Skills and Qualifications:

  1. B.S. preferred.
  2. 3-5 years of work experience in a related industry.
  3. Strong PC skills (Word, Excel, Access, etc.).
  4. Able to read and understand complex procedures.
  5. Strong Organizational skills, Decision Making , communication and Teamwork is a must.
  6. Previous experience with the media production/manufacturing environment, procedures and  processes and working knowledge of MES systems if preferred but not required
  7. Experience with SAP transactions to create, change and view in various modules including ECM.
  8. Experience with Electronic Systems for document housing, retrieval, and processing
  9. Working Knowledge and working experience of GMP, GLP and GDP’s.
  10. Working knowledge and work experience dealing with regulatory agency (e.g., FDA and ISO) requirements preferred.
  11. Knowledge and understanding of microbiology and or chemistry DOE is desired

 

 

Additional Information:

  • Lifting (up to 25 lbs) office products and supplies and moving containers of  various materials.
  • Operating within cool temperature and low humidity conditions within the production room.
  • Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. 
  • Excellent personal hygiene required. 

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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