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 roleis 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
Supportsthe technical transfer, qualification, and validation of QC methods for raw materials.
Contributesto the design and execution of analytical studies to assess the qualityofcelltherapycontrolledmaterials.
Quality Control Operations
Perform routine raw material testing, analysis, and releasein accordance withcompendial methods such as USP and EP, internal test methods, standard operatingproceduresand specifications, ensuringtimelyavailability of released materials to support manufacturing and compliance with regulatory and quality standards.
Maintain the QC laboratory and equipment in accordance withapproved 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 isrequired.
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 suchas 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
The annual base pay for this position ranges from $79,367.20 - $119,050.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
06-May-2026Closing Date
12-May-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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