Quality Assurance At-the-Source Lead, Cell Therapy

AstraZeneca • Rockville, MD

6d • 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. The Quality Assurance team is valued for its forward-looking mindset, working at the forefront of product lifecycle management, ensuring reliability and excellence through innovation and the latest technologies. This position empowers individuals to make decisions that prioritize patient safety, guided by science and evidence.

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
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED