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Document & Data Specialist - Engineering

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Location: Saint Louis, 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.

 

 



 

 

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 document reviews, intra-, /extra-departmental audits and supports departmental projects as required.

 

PRIMARY DUTIES:

 

  • Generate, maintain, and revise all electronic and hard copy controlled documents in accordance with company policies and regulatory agency (e.g., FDA and ISO) requirements.
  • Review and process all document change requests (CRs) in compliance with company policies.
  • Maintain filing system for hard-copy documents.
  • Maintain and review the training curriculum for employees in the Engineering Documentation department.
  • Support departmental projects as required.
  • Expectation to have the capacity to understand all 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.

 

KNOWLEDGE, EXPERIENCE & SKILLS:

 

  • Bachelor's Degree.
  • In lieu of Bachelor’s degree: Five (5+) years in card production with at least a Production Tech 3 Certification or in a Production Specialist preferred.
  • Five (5+) years of card production work experience with Production Tech 3 certification preferred.
  • Ability to collaborate professionally with all levels of personnel in a cross-functional team environment is required.
  • Knowledge of FDA/ISO regulations and process validation is preferred.
  • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Must have strong communication and interpersonal skills.
  • Must have strong analytical and problem-solving skills.
  • Decisions with regard to SOP and process improvements related to card production, line maintenance, and engineering documentation.

 

 

Working Conditions:

 

  • Standing, repetitive hand and arm motions, ability to climb steps.
  • Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed 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. 
  • Appropriate gowning requirements necessary for the production areas. 
  • Gloves are required to handle the product.
  • Hairnet, clean room gowns, and/or lab coats are required.
  • Safety glasses and hearing protection are required personal protective gear. 
  • Occasional environmental odors may be prevalent. 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA

 

 

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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