Quality Document and Change Specialist

bioMerieux Inc.
United States, Missouri, Hazelwood
595 Anglum Road (Show on map)
Feb 27, 2025
Quality Document and Change Specialist Location: Hazelwood, MO, United States Position Type: Unfixed Term Job Function: Quality Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux 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 6,200 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. Description Position Summary & Responsibilities: This Quality Specialist role is responsible for supporting representation for quality related change projects, tracking risk mitigation requirements, and required project collaborations for clear communication. In this role you will be responsible for processing and tracking document revisions, change controls, departmental trending, and some system admin oversight. Utilization of LLDC Document System and Trackwise to process revisions and changes Serve as a contact for quality related departmental projects for reagents and instruments (equipment, expansions, testing, etc.) Utilize project management tools to maintain organized records of action items Collaborate with SMEs in departments to maintain clear oversight to project requirements, impacted documents or procedures, and project costs. Support utilization of risk management skills to identify and address impacts to projects Education, Skills, & Experience: Bachelors degree with 3+ years of GMP experience Associates degree with 5+ years of GMP experience also accepted High School Diploma or GED with 7+ years of progressively responsible and related GMP experience also accepted Experience working in a FDA production environment Prior knowledge of MES, SPC, or SAP a plus Strong PC skills including proficiency in Excel, PowerPoint, Outlook, Word, Visio, and Project Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize quality system tools and techniques effectively. Strong time management skills and accountability 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. #biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 recruitment@biomerieux.com. BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS). Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now >