Quality Specialist

Biofire Diagnostics•Hazelwood, MO

9d•$73,000 - $102,900

About The Position

A world leader in the field of in vitro diagnostics for more than 60 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 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 globalpany with a long-term vision, and a human-centered culture. Description Position Summary Responsible for ensuringpliance and following all regulations and quality systems within our international distribution centers. Perform time and temperature analysis for shipments within the US and LATAM distribution network. Responsible for creating quality events, obtaining dispositions, and product release for products at US distribution centers.

Requirements

Bachelor's degree in a scientific or technical field (biology, chemistry, engineering, statistics), including Pharmaceutical or Medical Device experience, or related field.
Minimum 2+ years of professional related experience in scientific or technical field (pharmaceuticals or clinical laboratory, biological, chemical, engineering, or statistical related fields).
Experience in data analysis, interpreting laboratory results, and working in a scientific setting.
Effective written and oralmunication skills.
Competence in the selection and use of Quality Engineering tools, techniques, and processes.
Strongputer skills including Microsoft Office (Excel, Word, etc.).
Flexibility in responding to unexpected demands and ability to work in a team environment, building effective working relationships.
Knowledge of GMP, ISO, and FDApliance.
Critical thinking, adaptability, time management,munication, and problem-solving.
Technical learning aptitude to quickly acquire new knowledge and skills.
Ability to lead without authority through influence and guidance.
Effective problem analysis and decision-making.
Detail orientation and ability to managepeting deadlines.
Technical writing skills; knowledge of bioMérieux reagents and instruments preferred.
Ability to ascend/descend stairs, ladders, ramps, and similar structures.
Ability to adjust or move objects up to 50 pounds in all directions.
Domestic travel required: approximately 10%.
International travel required: 0%.
Typical office setting, including sitting and typing; some warehouse tasks required.

Nice To Haves

Technical writing skills; knowledge of bioMérieux reagents and instruments preferred.

Responsibilities

Evaluate shipments using Time and Temperature out of Range (TTOR) and Mean Kinetic Temperature (MKT) principles.
Initiate quality events, liaise with manufacturing sites for dispositions and distribution centers for product release.
Execute assigned quality projects, with guidance from technical quality expert (depending on level of experience), using engineering principles, business standards, practices, procedures, and project requirements.
Assure proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.
Communicate the quality status of materials to internal customers, management, and external suppliers.
Develop and implement departmental operational procedures to ensure regulatorypliance (FDA, GMP, ISO, OSHA, etc.).
Make rmendations for improving quality & productivity performance.
Contribute continuous product and process improvements in areas related to department.
Lead activities contributing to QMSpliance: CAPA (including analysis of data and trends inplaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, etc.
Work with other departments to ensure operational and quality goals are understood and met.
Participate andmunicate status, business issues, and significant developments in projects.
Develop and review procedures (both internal and external).
Perform all work inpliance withpany quality procedures and standards.
Perform other duties as assigned.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves