Quality Assurance Specialist

AstraZeneca plc; Santa Monica (CA); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Short-term incentive

Equity-based awards

401(k) plan

Paid time off

Job summary

AstraZeneca plc is seeking a Specialist, Quality in Tarzana, CA to ensure compliance with quality systems and regulatory guidelines. The role covers QA responsibilities for production and disposition of products manufactured for AstraZeneca, reporting to the QA Manager.

The position requires a BA/BS in biological sciences or related field and 2–4 years GMP industry experience. It emphasizes cGMP knowledge, regulatory excellence and investigations closure, with office-based three-day-per-week

Qualifications

• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Adapt best practices for stage appropriate products.

Responsibilities

• Provide quality assurance support across technical operations functions to assure compliance to the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, with CAPA and VoE, drive timely closure.
• Manage change controls in a phase appropriate manner for clinical stage products supporting quality risk management.
• Provide ILT trainings for GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
• Issue batch record documentation to manufacturing and review QC data for disposition and lot closure.
• Approve equipment alarm acknowledgements, activation and PM/Calibration schedules in asset/alarm systems.
• Review routine material release documentation for quality release of raw materials.

Skills

GMP regulations

Regulatory compliance

CAPA management

Investigations

Change control

Education

BA/BS in biological sciences or related field

Job description

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our fervor for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Specialist, Quality ensures compliance with quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This unique role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of Astrazeneca. This role is based in Tarzana, CA, and reports to the Manager, QA.

Responsibilities

• Provide quality assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within AstraZeneca to assure compliance to the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, respectively, with cross-functional owners. Determine corrective/preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive timely implementation and closure.
• Work with appropriate partners to manage change controls in a phase appropriate manner for clinical stage products that supports quality risk management (i.e. New Product Introduction, New Facility, & Manufacturing Process Change Controls).
• Provide ILT trainings for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media batch records and in-process/QC/final product labels) to manufacturing.
• Review routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Perform approval of equipment alarm acknowledgements, equipment activation and PM/Calibration schedules in computerized asset and alarm management system(s).
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.

Education And Experience

• BA/BS in biological sciences or a related field is required
• 2-4 years GMP regulated industry experience..
• Proficient in cGMP regulations, quality systems and regulatory
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Adapt best practices for stage appropriate products.

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan \
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

The annual base pay (or hourly rate of compensation) for this position ranges from $100,880.80 - $151,321.20. 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 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

20-Oct-2026

Closing Date

30-Oct-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.