QC Associate – Global Cell Therapy Raw Materials

AstraZeneca plc; Rockville (MD); On-site; USD 56,000 - 84,000; Full time

Benefits offered by this job

Retirement programs

Paid time off

Health, dental, and vision coverage

Short-term incentive bonuses

Equity-based awards

Commissions for sales roles

Job summary

AstraZeneca plc in Rockville, MD seeks a QC Associate to perform GMP analytical testing of raw materials for Cell Therapy manufacturing, follow approved methods, and maintain documentation to support timely material testing. The role covers raw-material testing, lab upkeep, method transfer support, and collaboration across the Cell Therapy network; requires a B.S./M.S.

in a related field and experience with analytical techniques.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific field.
• 2+ years of relevant experience for Associate level (B.S.) or 0+ years with M.S.
• Experience with analytical techniques and GMP documentation.

Responsibilities

• Perform routine and non-routine raw-material testing using approved methods and SOPs.
• Maintain a safe, clean, inspection-ready QC laboratory.
• Complete accurate GMP documentation and support lab reports.
• Support method transfer, qualification, validation, deviations and investigations.

Skills

Analytical techniques

cGMP knowledge

Data integrity

Documentation

Safety

Communication

Team collaboration

Procedures follow

Education

Bachelor’s or Master’s degree in biological sciences, chemistry, biochemistry, or related field

Tools

ELN/LIMS/SAP experience

Job description

Position Summary

The QC Associate performs GMP analytical testing of raw materials used in Cell Therapy manufacturing and supports the day-to-day readiness and operation of the QC laboratory. The role follows approved methods and procedures, completes accurate documentation, and supports timely testing of materials in accordance with applicable quality, regulatory, site, and global requirements. Testing may include chemical and physical analyses, compendial methods, immunoassays, and cell-based assays, as applicable.

Key Responsibilities

• Raw-Material Testing and Analysis
  • Perform routine and non-routine raw-material testing using approved methods, SOPs, specifications, and protocols for material release or disposition.
  • Complete testing accurately and within agreed timelines to support manufacturing requirements.
  • Support raw-material qualification and testing activities, as needed.
  • Review results and promptly escalation atypical findings, deviations, equipment issues, and data-integrity concerns.
• Laboratory and Equipment Upkeep
  • Maintain a safe, clean, orderly, and inspection-ready QC laboratory.
  • Support the management of laboratory equipment, reagents, standards, consumables, inventory, and waste.
  • Perform routine equipment checks and support calibration, maintenance, qualification, and service activities.
• Documentation
  • Complete accurate, timely, and traceable GMP documentation in accordance with good documentation practices and data-integrity requirements.
  • Support the preparation and review of applicable laboratory documents, including SOPs, work instructions, methods, protocols, and reports.
• Others
  • Support assigned method transfer, qualification, validation, deviation, investigation, and change-control activities.
  • Participate in appropriate continuous improvement activities that enhance laboratory efficiency, compliance, and right-first-time execution.
  • Work collaboratively cross functionally across the Cell Therapy network.

Education and Experience

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

• Associate level: B.S. with 2+ years of relevant experience, or M.S. with 0+ years of relevant experience

Required Skills

• Experience with, or exposure to, analytical techniques appropriate to the laboratory, which may include pH, FTIR/Raman, HPLC, ELISA, wet chemistry, and cell-based assays.
• Working knowledge of cGMP, good documentation practices, data integrity, and laboratory safety.
• Awareness of applicable compendial requirements, including USP and EP.
• Ability to follow written procedures and complete work accurately and on time.
• Strong attention to detail, documentation, problem-solving, and communication skills.
• Ability to recognize and escalation testing, equipment, documentation, or procedural issues.
• Ability to work effectively in a collaborative, cross-functional team environment.

Preferred Skills

• Experience supporting raw-material testing or other GMP laboratory activities.
• Experience working with short turnaround times while maintaining quality and compliance.
• Experience with digital laboratory systems, such as electronic laboratory notebooks, LIMS, or SAP.
• Familiarity with Cell Therapy, biologics, or advanced therapy manufacturing environments.

Annual Base Pay

The annual base pay (or hourly rate of compensation) for this position ranges from $55,920.80 to $83,881.20. 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

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans
• short-term incentive bonuses
• equity-based awards for salaried roles
• commissions for sales roles

Inclusive Environment

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.