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Job Title: Quality Control Associate Location: Oro Valley, AZ Type: Contract Compensation: $25.75/hr Work Model: Onsite Hours: M-F normal business hours Security Clearance: Not specified

Overview Leave placeholder text here for recruiter to input

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. • Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods. • 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. • Manage lab supplies and inventory to support QC operations, including indirect materials, tissue kanbans, and retain samples. • Foster and follow established safety culture, environmental guidelines, and procedures. • Formulate reagents with high complexity for testing processes. • Serve as QC representative in transferring processes from development to QC. • Assist in testing raw materials for reliability and stability. • Support process monitoring, trending, and collection of process metrics for improvements. • Assist in performing, reviewing, and generating validations for QC processes and equipment. • Support reagent manufacturing activities outside of QC. • Maintain safety standards, report hazards/incidents, and ensure compliance with OSHA, FDA, and other regulations. • Conduct OOS investigations, non-conformance activities, and corrective actions. • Review and provide feedback on documentation changes. • Achieve 95% or above internal training compliance and maintain accurate records.

Qualifications • High School Diploma (required) • Associates or Bachelor’s Degree in Science or Life Science discipline (preferred) • 7+ years experience in regulated industry (or 3+ years with an Associate’s Degree, or less than 1 year with a Bachelor’s Degree) • Strong communication, data analysis, troubleshooting, and problem-solving skills • Hands-on laboratory experience with manual pipetting and measuring techniques • Attention to detail, organizational skills, and ability to meet deadlines • Proficiency with Google Suite and laboratory techniques such as titration, spectroscopy, and tissue testing • Preferred: experience handling corrosive and biohazardous reagents, working in GLP/cGMP/ISO environments, and Lean methodologies

Physical Conditions and PPE • Environment requiring gowning, hair net, safety glasses, gloves, foot coverings • Lift up to 25 lbs, with scheduled overtime, shift work, and standing for multiple hours

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic data, veteran status, marital status, or any characteristic protected by law.

#M- #LI- Ref: #558-Scientific