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Quality Specialist

Location: Hazelwood, MO, 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.

Description

Position Summary:

The Quality Specialist is responsible for lot related oversight for batch record completion.  This includes MES and paper documentation exception review, in process approval forms, segregation approvals, rework approvals, and participation in review boards.  

  • Individual will be responsible for releasing specialized lots related to deviations and investigations.
  • Individual may also support QA GEMBA for process and improvement opportunities
  • This QA role will be responsible for performing the lot release in SAP.
  • This QA role may be required to support continuous improvement 

Primary Responsibilities:

  • Review and approve In-Process MES exceptions, lot segregations, containment of rejected materials, and support changeover inquiries.
  • Upon collation of lot documentation from production and QC – perform SAP lot release
  • Support manufacturing and QC in the initiation of Trackwise deviations in real time, as applicable
  • Supports nonconformance investigations and product inspections using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.), as applicable.
  • Authors and reviews GMP documents including procedure revisions and specified reports, to support continuous improvement and the change control process.
  • Implements and completes continuous improvement projects as required.
  • Supports internal/external audits.

Education, Skills, & Experience:

  • Bachelors degree with 3 or more years of GMP experience
    • Associates degree with 5 or more years of GMP experience also accepted
    • High School Diploma/GED with 7 or more years of GMP experience also accepted in lieu of degree
  • Experience working in a GMP / FDA production environment
  • Exhibits strong analytical and problem-solving skills.  Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.
  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
  • Strong interpersonal skills and ability to work with all levels of an organization.
  • PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
  • Prior knowledge of MES, SPC, or SAP a plus

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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