Sr. Quality Specialist - Reagent Quality, (C-shift)

bioMérieux • Salt Lake City, UT

23d • $30 - $38

About The Position

We are seeking a highly skilled Sr. Quality Specialist to join our QA Reagents team. This role requires strong self-direction, excellent attention to detail, and the ability to work effectively in a fast-paced manufacturing environment. You will collaborate across departments, support quality system improvements, and ensure that products and processes meet regulatory, internal, and customer requirements.
The Sr. Quality Specialist plays a key role in reviewing high-level documentation, resolving non-conformances, supporting investigations, participating in process improvements, and ensuring the timely release of materials and finished goods.

Requirements

• High school diploma or equivalent is required
• Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required
• Completion of the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree).
• Ability to remain in a stationary position (sitting or standing) for extended periods.
• Ability to correctly wear PPE throughout the workday.
• Ability to lift or move up to 50 lbs.
• No domestic or international travel required.

Nice To Haves

• Associate degree (or higher) in a life science or engineering discipline is preferred.

Responsibilities

• Conduct final reviews of batch records to ensure compliance with internal and regulatory quality standards.
• Release product batches within established timelines.
• Lead quality investigations, including root cause analysis and corrective/preventive actions (CAPA).
• Review and approve risk analyses, manufacturing documentation, and change-related quality records.
• Support or perform troubleshooting for manufacturing discrepancies and defects.
• Assist with audits, customer complaints, and quality investigations.
• Train team members on documentation review processes and quality requirements.
• Maintain proper archiving and retrieval of batch records, ensuring audit readiness.
• Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
• Inspect product (including labeling) for compliance with procedures and specifications; determine product acceptance.
• Identify and escalate non‑conformances; partner with production to resolve issues where appropriate.
• Ensure accurate documentation practices during quality record review; resolve errors with production teams.
• Physically release work‑in-process for finished-goods production and archive quality records.
• Prioritize product release to meet departmental goals; report floor failures observed during routine sweeps.
• Review and approve Device History Records (DHRs). Receive and hold finished goods until authorized release.
• Release finished goods to stock; coordinate molded part validation inventory.
• Verify equipment meets requirements for release to Manufacturing Engineering for validation.
• Confirm equipment meets specifications for release to Reagent Manufacturing for use.
• Physically and electronically control all suspected non‑conforming material; review Nonconforming Product Reports (NCRs).
• Review and approve rework documentation; confirm it meets quality requirements.
• Disposition NCR‑related materials.
• Manage Temporary Change Orders (TCO) to ensure proper documentation across applicable records.
• Track TCO activation/expiration to determine when to remove, revise, or escalate to full change orders.
• Confirm all required validation documentation is completed prior to product release; control validation-related product until criteria are met.
• Perform all work in compliance with company quality 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED