Quality Assurance Associate
About The Position
AstraZeneca is seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team. 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 organize 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. Perform other duties as requested by supervisor/manager to support Quality. Administrative Tracking of QA metrics On the Floor QA support
Requirements
- BA/BS in Biology, Chemistry, Microbiology, Engineering, or a related field is required (no prior work experience needed). Alternatively, an Associate’s degree with up to 2 years of relevant experience or a High School diploma with up to 4 years of relevant experience is required.
- Must be 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.
- Demonstrated ability to take ownership, initiative, and self-accountability.
- Demonstrated 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.
Nice To Haves
- Relevant academic laboratory experience, coursework, or internships are a plus.
- Experience in Cell or Gene Therapy
- Well versed in various cell therapy manufacturing processes
Responsibilities
- 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.
- Perform other duties as requested by supervisor/manager to support Quality.
- Administrative Tracking of QA metrics
- On the Floor QA support
Benefits
- Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
