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.ResponsibilitiesReviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closureReview routine material release documentation for quality release of raw materials used for manufacturing and quality control testingWork with Doc Control to ensure archival of batch recordsWork with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media records and labels) to manufacturingProvide 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 relationshipsPerform other duties as requested by supervisor/manager to support QualityAdministrative Tracking of QA metrics On the Floor QA supportSkillsBA/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 requiredRelevant academic laboratory experience, coursework, or internships are a plusMust be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficienciesFlexibility of occasionally working in weekend or holidays to support lot releaseDemonstrated ability to take ownership, initiative, and self-accountabilityDemonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team settingAttention to detail and quick learning/application of concepts and informationKnowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applicationsAbility to communicate and work in a self-guided manner with scientific/technical personnelExperience in Cell or Gene TherapyWell versed in various cell therapy manufacturing processesBenefitsShort-term incentive bonus opportunityEquity-based long-term incentive programQualified retirement program [401(k) plan]Paid vacation and holidaysPaid leavesHealth benefits including medical, prescription drug, dental, and vision coverageCompany OverviewAstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor. It was founded in 1913, and is headquartered in Cambridge, Cambridgeshire, GBR, with a workforce of 10001+ employees. Its website is https://www.astrazeneca.com.Company H1B SponsorshipAstraZeneca has a track record of offering H1B sponsorships, with 2 in 2021, 11 in 2020. Please note that this does not guarantee sponsorship for this specific role.



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