Quality Systems and Testing Specialist
Job Description
Job Description
The Quality Systems & Testing Specialist supports compliance with 21CFR111 by maintaining key Quality Systems and overseeing testing programs that support product quality and regulatory requirements. This position is responsible for controlled documentation, data integrity initiatives, OOS/OOT investigations, CAPA activities, third-party testing programs, and stability testing. The role serves as a liaison between Life Extension and contract testing laboratories to ensure timely and accurate testing, reporting, and documentation.
Core Duties and Responsibilities:
• Manage all third-party testing programs (Consumer Labs, IFOS, Amazon, Wegman’s Verified with Confidence, and others), including sample submissions, tracking, result review, and reporting.
• Coordinate and oversee the Stability Testing Program, including sample management, testing schedules, result tracking, trend analysis, and reporting.
• Review Certificates of Analysis (CoAs) and testing documentation to verify compliance with company and regulatory requirements.
• Serve as the primary contact for contract laboratories to ensure timely testing and resolution of testing-related issues.
• Oversee Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations in accordance with company Standard Operating Procedures (SOPs) and regulatory requirements.
• Prepare and maintain CAPAs, SCARs, investigation reports, protocols, and supporting documentation related to raw materials and finished products.
• Ensure compliance with Good Documentation Practices (GDP), data integrity principles, GMP requirements, and company quality standards.
• Participate in internal and external audits, including third-party laboratory assessments and supplier evaluations.
• Manage controlled quality documentation, including specifications, testing records, investigation reports, and quality documentation.
• Ensure all physical and electronic records are maintained and archived in accordance with company record-retention requirements.
• Review QA/QC documentation for accuracy, consistency, completeness, and compliance.
• Provide testing documentation and technical support for wholesalers, regulatory agencies, and international market requirements as needed.
• Analyze technical documentation and laboratory data to support quality and compliance initiatives.
• Collaborate with Quality, Regulatory Affairs, R&D, Supply Chain, and Operations teams to support business objectives.
• 2 onsite days per week is an essential function of this position.
• Additional duties as needed
Position Requirements:
• Bachelor’s degree in Biology, Chemistry, Life Sciences or related scientific field
• 2+ years of experience in Quality Assurance, Quality Control, Laboratory Operations, or Quality Systems within the dietary supplement, pharmaceutical, food, or related regulated industry
• Working knowledge of 21CFR111, GMP requirements, Good Documentation Practices (GDP), and data integrity principles
• Familiarity with OOS, OOT< CAPA, deviation investigations, and change control processes
• Understanding of analytical testing methodologies, including HPLC, ICP-MS, FTIR and other laboratory techniques.
• Experience reviewing laboratory data, chromatograms, CoAs, and technical reports is preferred
• Excellent written and verbal communication skills
• Strong organization skills and detail oriented
• Ability to translate complex technical and laboratory information into business-friendly language
• Proficiency in Microsoft Office