Quality Control Associate

Job Title: Quality Control Associate
Location: Tucson, Client
Duration: 12 Months+
Shift: 1st Shift

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Position Summary

The Quality Control Associate Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing. The individual will be responsible for review, generation, and sign-off of quality documentation. The role requires interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment. The associate will maintain areas in a high state of inspection preparedness by maintaining equipment, records, and laboratory environment in compliance with regulatory requirements and Operating Procedures (OP). Responsibilities also include maintaining production documents, investigating Out of Specification (OOS) results, and working independently with general guidance from senior team members.

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Responsibilities

• Perform inspection and testing of raw materials, in-process materials, and finished goods in a compliant manner.

• Document test results, complete batch records, document observations, and generate reports for qualification testing.

• Conduct data analysis of raw material, in-process, and finished goods test results.

• Generate compliant QC documentation as part of the Device History Record required for releasing items into inventory.

• Maintain records and QC lab environment to comply with cGMP, OP, and regulatory requirements.

• Perform routine maintenance of laboratory equipment outlined by operating procedures.

• Assist in coordinating vendor activities for user-maintained laboratory equipment.

• Perform regular laboratory and manufacturing environmental monitoring testing.

• Handle lab supply ordering and inventory management to support QC laboratory needs (TECO, Cycle counts, etc.), including indirect materials, tissue kanbans, and retain samples.

• Foster and follow an established safety culture, environmental guidelines, and procedures.

• Formulate reagents with high complexity for material testing processes.

• Act as QC representative in transferring processes from development to QC.

• Assist in testing raw materials for reliability and stability, process monitoring, and trending.

• Assist in collecting, interpreting, and communicating process metrics for recommended improvements.

• Assist in performing, reviewing, and/or generating validations for QC processes and laboratory equipment.

• Assist in the development and implementation of testing processes.

• Assist in reagent manufacturing activities unrelated to QC.

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Quality and Safety, Compliance

• Maintain Right to Operate and ensure all processes are performed in a safe and healthy manner.

• Escalate unsafe hazards and report incidents or near misses using safety reporting tools.

• Navigate and understand the quality system, escalating issues when required.

• Perform tasks accurately in a regulated environment (OSHA, NMPA, FDA, etc.).

• Document all transactions and production instructions with accuracy related to materials handling in compliance with FDA, OSHA, QSR, ISO, GMP, and company policies.

• Ensure equipment compliance with calibration standards.

• Conduct OOS investigations and support non-conformance, reworks, and corrective actions.

• Act as QC representative in document review and provide feedback on changes.

• Maintain 95% or above internal training compliance.

• Maintain accurate records, including daily metrics.

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Continuous Improvement

• Conduct 6S activities and develop/follow standard work.

• Identify and implement process improvements using lean tools.

• Participate in team meetings and process improvement projects.

• Contribute to data collection for daily metrics and operational excellence initiatives.

• Perform other duties as assigned.

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Teamwork and Collaboration

• Collaborate with peers and other functions to achieve targets.

• Assist in onboarding and training new employees and contractors.

• Suggest improvements for work processes and laboratory equipment.

• Engage in cross-functional technical activities such as quality investigations and product design transfer.

• Update and edit standard operating procedures.

• Work with vendors, planners, and departments to ensure seamless integration.

• Assist in executing complex projects.

• May act as proxy for QC Leadership when required.

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Education

• High School Diploma

• Associate s or Bachelor s Degree in Science or Life Science discipline

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Experience

• 7 years work experience in regulated industry with HS Diploma

• 3 years work experience with an Associate s Degree

• Entry level (<1 year) with a Bachelor s Degree

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Knowledge, Skills, and Abilities

• Excellent oral and written communication skills.

• Strong data analysis, troubleshooting, and problem-solving skills.

• Hands-on laboratory experience.

• Accurate manual pipetting and measuring techniques.

• Attention to detail and strong organizational skills.

• Proficiency in Google Suite and other computer programs.

• Ability to meet deadlines and work effectively in teams.

• Proficiency in a wide range of moderate/high complexity lab techniques (titration, spectroscopy, protein analysis, tissue testing, etc.).

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Preferred

• Experience handling corrosive and biohazardous reagents.

• Experience in GLP, cGMP, or ISO regulated environments.

• Experience with 6S and Lean techniques.

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Physical Conditions & PPE Requirements

• Requires gowning, hair net, safety glasses, gloves, and foot coverings.

• Ability to lift up to 25 lbs.

• Possible overtime and shift work depending on business needs.

• Ability to stand, walk, sit, kneel, bend, crouch for 4+ hours per day.

• Ability to push, pull, and lift 25 lbs. with repetitive hand/wrist movements.

• Good near visual acuity required.