Quality Assurance At-the-Source Lead, Cell Therapy

AstraZeneca • Rockville, MD

8d • $100,880 - $151,321 • Onsite

About The Position

Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) Lead, 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. AstraZeneca is investing in internal capabilities to realize its ambition of discovering and delivering next-generation cellular therapies. The Quality department is valued for its forward-thinking mindset, working at the forefront of product lifecycles, and ensuring patient safety through innovation and excellence. This is a place where you can step up, follow science, and make decisions that put patients first, contributing to accelerated growth and improved lives.

Requirements

• 7+ years applicable quality experience with B.S. degree in Science, Engineering, or related technical field
• 11+ years applicable with Associates degree
• 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

• Supports team members by facilitating scheduling and personnel coordination, removing roadblocks and mentoring in complex situations.
• 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 labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
• Supports the issuance and reconciliation of cGMP documentation.
• Reviews and/or approves executed batch records, equipment logs, etc.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior