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.
This position is to investigate and manage day to day Non Conforming Material-NCMR’s. When raw materials and/or product does not meet specification, the role of the investigator is to follow procedures that will help guide them in the development of writing an investigation to determine root cause and possible corrective actions to the problem.
- Investigate and manage day to day Non Conforming Material-NCMR’s related to raw materials and/or finish good in the manufacturing process. (This will encompass the majority of your time)
- Evaluate, develop, and improve manufacturing processes by studying product and manufacturing methods.
- Collaborate with Supply Chain, Reagents Operations Engineering, Incoming QC, Final QC, Manufacturing, Quality, and Purchasing to identify and lead material and/or finish good related issues to ensure optimum manufacturing process in terms of keeping manufacturing moving.
- Manage materials related to quality issues in the area of Tape, Webbing, Tubing, and Card production.
- Provide daily decisions on service, manufacturing, and engineering to ensure product quality.
- Participate in the development of long-term strategies for materials and process improvements.
- Conduct validations and feasibility studies to assess new technologies or process improvements in material or process design.
- Support CAPA’s with regard to root cause analysis and fishbone activities related to material and/or manufacturing processes.
- Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
- Ensure that all health, safety, and environmental requirements are fulfilled.
- Support the development of capital business cases for new material/process/equipment development projects.
- Help Resolve quality related issues on the manufacturing floor and/or incoming QC.
- Obtain and analyze data, as required, to ensure key metrics, such as, but not limited to OEE, MSP, and yield are achieved.
Studies and Experience:
- Bachlors Degree required in Scientific/Engineering Area: Such as Biology, Chemistry, Manufacturing/Mechanical Engineering is required.
- 3+ years of Non-Conforming investigation writing is preferred.
- 3+ years of experience working in an FDA Regulated Environment is preferred.
Skills and Qualifications:
- Background working in a high volum manufacturing setting.
- Ability to collaborate professionally with all levels of management 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.
- Extensive standing, repetitive hand and arm motions, ability to climb steps.
- Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.
- Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
- 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.
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).