Quality Assurance Disposition Senior Specialist, Cell Therapy
About The Position
Join AstraZeneca's Global Quality Operations team as a Quality Assurance Disposition Senior Specialist, Cell Therapy at the Rockville Manufacturing Center (RMC) facility. This role is crucial in delivering life-saving cell therapies and making a direct impact on patients. The position involves fostering an attitude of excellence and contributing to the company's ambition to discover and deliver next-generation cellular therapies. Quality Operations is a valued department where employees work at the forefront of product lifecycle management, ensuring reliability and excellence through innovation and the adoption of the latest technologies. The role empowers individuals to make decisions that prioritize patient safety, guided by science and evidence.
Requirements
- 10+ years applicable quality experience with B.S. degree in Science, Engineering, or related technical field
- 15+ years applicable with High School Diploma
- Experience writing and investigating quality records
- Proven ability to work in a fast-paced environment across multiple technical functions
- Strong knowledge of cGMPs
- Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply
Nice To Haves
- M.S degree in Science, Engineering or related technical field
- Autologous cell therapy manufacturing or quality experience
- Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance
Responsibilities
- Assures the quality and compliance for commercial and clinical products manufactured at the facility.
- Reads, understands, and follows SOP’s and complies with cGMP.
- Writes and/or revises Quality documentation utilizing electronic document management systems.
- Supports the evaluation and disposition of finished drug products through timely evaluation of batch records, laboratory results and other cGMP documents.
- Reviews and/or approves executed batch records, equipment logs, etc.
- Supports and guides other more junior quality assurance staff on complex situations.
- Supports internal audits of manufacturing, analytical testing, labeling, etc. to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program.
- Supports continuous improvement efforts.
- Participates in cross-functional Tier meetings.
- Ability to work "off-hours" as needed to support release of product to meet patient dosing needs.
- Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in the Electronic Quality System.
- Assists with deviation investigation and root cause analysis.
Benefits
- Qualified retirement program (401(k) plan)
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
- Short-term incentive bonus opportunity
- Eligibility to participate in our equity-based long-term incentive program (salaried roles)
- Retirement contribution (hourly roles)
- Commission payment eligibility (sales roles)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
