QC Specialist – Global Cell Therapy Raw Materials

Position Summary 

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. 

Key Responsibilities 

Method Development 

• Executes method development activities to support raw material qualification in preparation for commercial manufacturing. 

Technical Transfer and Analytical Execution 

• Supports the technical transfer, qualification, and validation of QC methods for raw materials. 

• Contributes to the design and execution of analytical studies to assess the quality of cell therapy controlled materials. 

Quality Control Operations 

• 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. 

Education and Experience 

• A bachelor’s or master’s degree, or equivalent, in biological sciences, chemistry, biochemistry, or a related field is required. 

• 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 

Required Skills 

• 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 

Preferred Skills 

• Experience performing or managing raw material analytical testing with short turnaround times 

• Experience with digital laboratory systems such as electronic notebooks, LIMS, and SAP