Quality Assurance At-the-Source Specialist, Cell Therapy

AstraZeneca • Rockville, MD

7d • Onsite

About The Position

Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) 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 Quality team is dedicated to ensuring product quality and compliance throughout the product lifecycle, innovating with the latest models and technologies to improve reliability and excellence. This position offers an empowered environment to make decisions that prioritize patient safety, guided by science and evidence.

Requirements

• 5+ years applicable quality experience with B.S. degree in Science, Engineering or related technical field
• 9 + years applicable with Associates degree
• 13 + years applicable with High School Diploma
• 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

• 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 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.
• Provides significant on-the-floor, real-time support of manufacturing operations in Grade C and Grade B environments.
• 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.

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
• Education Level: High school or GED