Senior Quality Assurance Associate

Job Title: Senior Quality Assurance Associate Duration: 3 Months (Potential Temp-to-Hire) Location: San Diego, CA (Onsite) Shift: Monday Friday, 8:00 AM 4:30 PM Job Summary: We are seeking a Senior Quality Assurance Associate to support clinical and commercial operations in a GMP-regulated environment. This role ensures all activities are compliant with cGMP, regulatory requirements, and SOPs, while supporting clinical trial projects, product release, and quality systems. Key Responsibilities: Ensure products are manufactured, packaged, tested, and released in compliance with regulatory standards Perform batch record review, product release, and documentation review Act as lead investigator for deviations, complaints, and non-conformance issues Review and track deviations, CAPA (Corrective and Preventive Actions), and investigations Conduct in-process audits, line clearance, and shipment verification Support label control processes including approval, release, and tracking metrics Assess incoming/damaged materials and ensure compliance standards are met Ensure testing methods are validated and equipment is calibrated Maintain audit readiness and support internal/external audits Collaborate cross-functionally to support clinical trial packaging and distribution Participate in Continuous Improvement (CI) projects using a risk-based approach Support data compilation, reporting, and quality review meetings Required Qualifications: Bachelor s or Master s degree in a scientific discipline (or equivalent experience) 10+ years of Quality Assurance experience in a GMP manufacturing environment Strong understanding of: cGMP regulations Quality systems & compliance Deviation & CAPA processes Preferred Qualifications: Six Sigma or ASQ Certification Experience in clinical trial support / pharmaceutical / biotech environments Key Skills & Competencies: Strong ability to analyze and resolve quality issues (routine & non-routine) Experience identifying and mitigating compliance risks and data discrepancies Ability to interpret and defend regulatory requirements Strong documentation, review, and audit skills Proven leadership and stakeholder management experience Ability to work in a matrix environment and collaborate across teams Effective communication skills to handle customer discussions and escalations Work Environment: Onsite role in a regulated GMP environment Opportunity for temp-to-hire based on performance and business needs

Created: 2026-04-02