What are the responsibilities and job description for the Sr Scientist (Medical Technologist/Microbiologist) position at bioMerieux Inc.?
Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Other
A family-owned company, bioMerieux 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
PRIMARY DUTIES
- As a subject matter expert, support final QC product performance data review to assess any clinical significance/implication that may occur.
- Write and execute protocols, author and present technical reports as needed; maintain a laboratory notebook, author/review internal SOPs
- Promptly investigate to identify the root cause of manufacturing issues which could lead to scrap lots of packaged finished products.
- Create and present reports on conducted experiments, failure investigations and validations to management.
- Manage projects related to investigating failures in current product production or testing processes. Validate corrective actions. Monitor the implementation of preventive actions and process improvements resulting from these failure investigations.
- Conduct CAPA investigations and support customer complaint investigations; including any corrective actions that may be identified.
- Provide technical expertise to projects related to manufacturing process improvement and/or new product development in order to meet market demands and drive down the cost of goods sold (CGS).
- Perform Risk Analysis for validations when required to reduce production and vendor-related risks. This task involves understanding the manufacturing environment and the details associated with implementing process/cost improvements.
KNOWLEDGE, EXPERIENCE & SKILLS
- BS in Biology, Microbiology, Medical Technology/Clinical Laboratory Scientist, MS in Clinical Microbiology or Biology (desired)
- Minimum of 5 years' experience in biological sciences OR 3 years clinical laboratory experience in Microbiology
- Strong PC skills (Word, Excel, Access, etc.).
- Knowledge of ISO 9001 and Quality System Regulation.
- Working knowledge of utilizing statistical software packages,eg minitab, SigmaStat (desired)
- Familiarity with a GMP production environment, procedures and processes desired
- Strong Organizational skills, decision making, communication, teamwork, and troubleshooting skills
- Statistics Knowledge (desired)
- LEAN manufacturing experience (desired)
- Six Sigma process knowledge and working experience of GMP, GLP and GDP's (desired)
- Knowledge and work experience dealing with regulatory agency (e.g., FDA and ISO) requirements (desired)
WORKING CONDITIONS
- Domestic travel requires 10 % of time.
- International travel required <5 % of time.
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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 , or by dialing 711 for access to Telecommunications Relay Services (TRS).
