Quality Assurance Associate
AstraZeneca is seeking an energetic and experienced individual with a cell therapy quality assurance background to join their Quality Assurance (QA) team. The successful candidate will perform QA batch record review, label review and verifications, and manage timelines for batch record reviews to support the advancement of the product pipeline.
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
Skills
- 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
- Relevant academic laboratory experience, coursework, or internships are a plus
- 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
- Experience in Cell or Gene Therapy
- Well versed in various cell therapy manufacturing processes
Benefits
- Short-term incentive bonus opportunity
- Equity-based long-term incentive program
- Qualified retirement program [401(k) plan]
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
Company Overview
Company H1B Sponsorship