Quality Assurance Specialist II – Onsite Location: Oceanside, CA. Contract: July62026– July52027 (12‑month onsite). We are seeking a highly motivated individual to join as a Quality Assurance Specialist. This role will execute a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. Standard work week Monday‑Friday; weekend and night work required during manufacturing campaigns. Responsibilities Perform Quality Assurance related production activities (Batch Record review, Line Clearance, and on‑floor support) Provide QA oversight/approval of QC activities (Method transfer, Certificate of Analysis, and Stability) Approve shipments and provide oversight during packaging Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls Ensure timely assessment and closure of Laboratory Investigations Ensure timely assessment and closure of batch and material hold events Communicate lot disposition pending issues to Management Provide on‑floor QA oversight and support to ensure compliance to GMP throughout the areas Perform walk‑throughs and process observations Perform Document Control activities including archival and updating of site training records Support Regulatory Body Inspections of the facility Ensure products are manufactured in compliance with regulatory and GMP guidelines Escalate issues that may adversely impact timely release of product Identify compliance risks and escalations to appropriate levels of management for resolution Generate and update procedures and forms as needed Requirements Master's Degree in the biological sciences or related field Bachelor's Degree and 2 years of experience in the biological sciences or related field AA Degree and 4 years of experience in the biological sciences or related field High School Degree and 5 years of experience in the biological sciences or related field Desired skills Quality Control background in Analytical, Virological, and Microbiological testing Working knowledge of GMPs in conformance to U.S. and EU standards Ability to negotiate and build collaboration among individuals Proficient in MS Word, Excel, Power Point and other applications Experience with Veeva, Smartsheet and LIMS desirable Excellent interpersonal, verbal and written communication skills Comfortable in a fast‑paced small company environment and able to adjust workload based upon changing priorities Pay $32.11–$42.11 per hour. Benefits Medical Vision Sick Pay (for applicable states/municipalities) ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #J-18808-Ljbffr
Quality Assurance Specialist II - Onsite • Oceanside, CA, United States
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