Associate, Quality Control Analytical, Cell Therapy at AstraZeneca

Rockville, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Apr, 26

Salary

94980.0

Posted On

25 Jan, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Laboratory Techniques, Cell Therapy, cGMP Awareness, Documentation Practices, Attention to Detail, Collaboration, Growth Mindset, Sample Preparation, Instrument Operation, Analytical Testing, Quality Systems, Training, Communication, Data Integrity, Aseptic Technique, PCR Setup

Industry

Pharmaceutical Manufacturing

Description

Associate, Quality Control Analytical, Cell Therapy Role Overview The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, completing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. Role Responsibilities Routine analytical testing: Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations. Sample and reagent preparation: Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs. Instrument operation: Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance. Documentation and data integrity: Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles. Lab support and readiness: Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes. Quality systems participation: Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls. Training and qualification: Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning. Collaboration and communication: Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines. Role Requirements Foundational technical skills: Basic hands-on experience with laboratory techniques relevant to cell therapy or biologics (e.g., pipetting, aseptic technique, ELISA basics, PCR setup, cell counting/viability). cGMP and GDP awareness: Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions. Organization and attention to detail: Strong focus on right-first-time execution, accurate record-keeping, and timely response to escalation of discrepancies. Collaboration and attitude: Demonstrates effective cross-functional collaboration, accepts flexibility in a constantly evolving environment, and maintains a positive, solutions oriented attitude to drive outcomes. Growth mindset: Enthusiasm to develop new technical skills and expand responsibilities with experience. Scheduling: Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines. Minimum Requirements: Education: Associate’s degree with relevant lab experience may be considered. Preferred: Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline. Experience: Industry/academic experience: At least one year of laboratory experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus. The annual base pay for this position ranges from $ 63,320.00 - $94,980.00 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 24-Jan-2026 Closing Date 01-Feb-2026 Our 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 is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Associate, QC Analytical, performs routine analytical testing and prepares samples and reagents for cell therapy products. They also maintain accurate documentation and assist with lab maintenance to support QC operations.