Quality Assurance Associate

AstraZeneca • Santa Monica, CA

1d

About The Position

The Quality Assurance Associate supports advancement of the product pipeline through batch record and label review, verification, record archival, and other quality tasks. The role independently coordinates and manages timelines for batch record reviews and provides support to the Santa Monica and Tarzana, California sites as needed.

The position reviews manufacturing batch documentation, quality control data, and material release documentation to support product disposition, lot closure, and raw-material release. It coordinates with Document Control to ensure records are archived and batch documentation is issued accurately. The associate also provides quality assurance support across technical operations functions to help maintain compliance with the quality manual and foster collaborative quality relationships. Additional duties include QA metrics tracking and on-the-floor support.

Requirements

• Bachelor of Science degree in biological sciences or a related field.
• 1–2 years of experience in a GMP-regulated industry.
• Ability to work on multiple projects simultaneously, with organizational, prioritization, and time-management proficiency.
• Flexibility to occasionally work weekends or holidays to support lot release.
• Ability to take ownership, initiative, and self-accountability.
• Ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
• Attention to detail and ability to quickly learn and apply concepts and information.
• Knowledge of cell culture techniques.
• Proficiency in MS Word, Excel, PowerPoint, and other applications.
• Ability to communicate and work in a self-guided manner with scientific and technical personnel.

Nice To Haves

• Experience in cell or gene therapy.
• Familiarity with various cell therapy manufacturing processes.

Responsibilities

• Review routine manufacturing batch documentation and quality control data for in-process and finished products to support disposition and lot closure.
• Review routine material release documentation for quality release of raw materials used in manufacturing and quality control testing.
• Coordinate with Document Control to ensure archival of batch records.
• Coordinate with QA Document Control to ensure accurate issuance of batch record documentation, including lot/media records and labels, to Manufacturing.
• Provide quality assurance support across technical operations functions, including Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, and Product Development/Manufacturing Sciences & Technology, to assure compliance with the quality manual and maintain collaborative quality relationships.
• Handle other duties as requested by the supervisor or manager to support Quality.
• Track QA metrics administratively.
• Provide on-the-floor QA support.
• Independently coordinate and manage timelines for batch record reviews.
• Provide support to the Santa Monica and Tarzana, California sites as needed.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level