Quality Control Associate Reagent Manufacturing

Role: Quality Control Associate – Reagent Manufacturing

Location: 1910 East Innovation Park Drive, Tucson, AZ 85755

Contract Duration: 12 Months (Potential for Extension or Full-Time Conversion)

Pay Rate: $20.00 – $25.75/hour + Benefits

Benefits: Weekly Pay | Medical | Dental | Vision Insurance

• Strong analytical and problem‑solving abilities
• Excellent communication and organizational skills
• Ability to lift 20–25 lbs and stand for extended periods

We are seeking a detail‑oriented Quality Control Associate – Reagent Manufacturing to support raw material and finished goods testing in a regulated manufacturing environment. This role is responsible for quality documentation, data analysis, laboratory compliance, environmental monitoring, and maintaining inspection readiness in accordance with ISO 13485, cGMP, and regulatory standards.

The ideal candidate will thrive in a fast‑paced laboratory setting, demonstrate strong technical and troubleshooting skills, and collaborate cross‑functionally to support quality and manufacturing operations.

• Perform inspection and testing of raw materials, in‑process materials, and finished goods in compliance with established procedures.
• Record test results, complete batch records, document observations, and generate qualification reports.
• Analyze test data and support quality decision‑making processes.
• Prepare and maintain compliant QC documentation for Device History Records and product release activities.
• Maintain laboratory records, equipment, and environment to meet cGMP, operational procedures, and regulatory requirements.
• Conduct routine laboratory equipment maintenance and support vendor coordination when required.
• Perform environmental monitoring activities for laboratory and manufacturing areas.
• Manage laboratory inventory, supply ordering, cycle counts, and inventory control processes.
• Support reagent formulation activities for testing processes.

• Ensure compliance with FDA, OSHA, ISO, QSR, and internal quality standards.
• Investigate Out‑of‑Specification (OOS) results and support non‑conformance investigations and corrective actions.
• Maintain calibration compliance for laboratory equipment.
• Review and provide feedback on document changes and procedural updates.
• Promote and maintain a strong safety culture by identifying and escalating workplace risks.
• Maintain complete, accurate documentation and achieve internal training compliance targets.

• Participate in Lean and 6S initiatives to improve operational efficiency.
• Support process improvement projects and operational excellence programs.
• Collect and report performance metrics to support business improvements.
• Contribute to team meetings and ongoing optimization initiatives.

• Partner with cross‑functional teams including vendors, planners, and operational groups.
• Assist with onboarding and training new employees and contractors.
• Support quality investigations, product transfers, and technical projects.
• Update and maintain standard operating procedures (SOPs).
• Provide backup support for QC leadership when required.

• High School Diploma required
• Associate’s or Bachelor’s Degree in Science or Life Sciences preferred

• 7+ years of experience in a regulated industry with a High School Diploma, OR
• 3+ years of experience with an Associate’s Degree, OR
• Entry‑level opportunity for candidates with a Bachelor’s Degree

• Strong verbal and written communication skills
• Excellent analytical, troubleshooting, and problem‑solving abilities
• Hands‑on laboratory experience
• Precise pipetting and measurement techniques
• Strong attention to detail and organizational skills
• Proficiency with Google Workspace and computer applications
• Ability to meet deadlines and work collaboratively
• Experience performing moderate to complex laboratory techniques

• Experience handling corrosive and biohazardous reagents
• Experience working in GLP, cGMP, or ISO‑regulated environments
• Familiarity with Lean and 6S methodologies

• Work in a controlled environment requiring PPE (gown, hairnet, gloves, safety glasses, foot coverings)
• Ability to lift and move up to 25 lbs
• Ability to stand, walk, bend, crouch, and perform repetitive hand movements for extended periods
• Flexibility to work overtime or shifts based on business needs