Quality Assurance Associate

Quality Assurance Coordinator

The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently coordinate and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed.

Responsibilities include, but are not limited to:

• Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Work with Doc Control to ensure archival of batch records.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media records and labels) to manufacturing.
• Provide quality assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within AZ to assure compliance with the quality manual and maintain collaborative quality relationships.
• Handle other duties as requested by supervisor/manager to support Quality.
• Administrative Tracking of QA metrics
• On the Floor QA support

Qualifications:

• BS in biological sciences or a related field is required.
• 1-2 years of experience with GMP regulated industry.
• Able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Flexibility of occasionally working in weekend 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 quick learning/application of concepts and information.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.

Preferred Qualifications:

• Experience in Cell or Gene Therapy
• Well versed in various cell therapy manufacturing processes

The annual base pay (or hourly rate of compensation) for this position ranges from $55,920.80 - $83,881.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.