Quality Assurance Associate
About The Position
The Quality Assurance Associate contributes to the advancement of the product pipeline by performing QA batch record and label reviews, verifications, document archival, and other assigned tasks. The associate independently coordinates and manages timelines for batch record reviews and provides support to the Santa Monica, California and Tarzana, California sites as needed. The role provides quality assurance support across technical operations functions to help ensure compliance with the quality manual and maintain collaborative quality relationships. It includes routine manufacturing and material-release documentation review, administrative tracking of QA metrics, and on-the-floor QA 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 and demonstrate organizational, prioritization, and time-management proficiencies.
- 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 learn and apply concepts and information quickly.
- 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.
- Well-versed in 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.
- Work with Document Control to ensure archival of batch records.
- Work 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 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.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Commissions for sales roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
