QC Specialist – Global Cell Therapy Raw Materials

AstraZeneca•Rockville, MD

2d•Onsite

About The Position

We are seeking a QC Specialist to support raw material qualification, testing, and release across the Cell Therapy network. This role is responsible for method development, technical transfer, analytical testing, and material release activities to ensure raw materials used in manufacturing meet required standards for quality, safety, and regulatory compliance. This role will support multiple clinical manufacturing facilities at AstraZeneca’s Rockville, MD and Gaithersburg, MD locations. The successful candidate will bring experience in GMP Quality Control, good documentation practices, and right-first-time execution, with a strong ability to work across analytical, operational, and cross-functional activities. Testing may include immunoassays, chemical and physical analyses, and cell-based assays.

Requirements

A bachelor’s or master’s degree, or equivalent, in biological sciences, chemistry, biochemistry, or a related field.
For Associate level: B.S. with 2+ years of relevant experience, or M.S. with 0+ years of relevant experience
For Specialist level: B.S. with 5+ years of relevant experience, or M.S. with 3+ years of relevant experience
Experience in method development, technical transfer, qualification, and/or validation
Hands-on experience with analytical techniques such as pH, FTIR/Raman, HPLC, ELISA, and wet chemistry compendial methods
Working knowledge of compendial requirements, including USP and EP
Experience in a Quality Control or GMP testing laboratory, with knowledge of cGMP and regulatory requirements for raw materials
Strong attention to detail, problem-solving, and documentation skills
Effective interpersonal, verbal, and written communication skills
Ability to work collaboratively in a high-performing team environment

Nice To Haves

Experience performing or managing raw material analytical testing with short turnaround times
Experience with digital laboratory systems such as electronic notebooks, LIMS, and SAP

Responsibilities

Execute method development activities to support raw material qualification in preparation for commercial manufacturing.
Support the technical transfer, qualification, and validation of QC methods for raw materials.
Contribute to the design and execution of analytical studies to assess the quality of cell therapy controlled materials.
Perform routine raw material testing, analysis, and release in accordance with compendial methods such as USP and EP, internal test methods, standard operating procedures and specifications, ensuring timely availability of released materials to support manufacturing and compliance with regulatory and quality standards.
Maintain the QC laboratory and equipment in accordance with approved procedures.
Author, revise, and review GMP documentation, e.g. SOPs, reports, etc.
Drive continuous improvement initiatives to enhance the efficiency, compliance, and effectiveness of QC operations.