New · posted Nov 12
AstraZeneca · Pharmaceuticals
Senior Stability Specialist, Quality Control
- Santa Monica, CA
- On-site
- Full-time
- Senior & Principal
The role
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 5 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to Role:
AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by supporting all stability testing across multiple products and sites. The Senior Stability Specialist, is a subject matter expert responsible for coordinating stability testing, facilitating stability execution, authoring stability report, managing EDAs, and leading all investigations related to stability. This individual will work closely with the QC operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Manger of Quality Control.
This position includes occasional weekend technical support and operates on one of the following shift, which is subject to change:
- Monday to Friday, 8:00AM - 4:30 PM
What you need
Accountabilities
- Author, review and execute Protocols and relating to Drug Product and Drug substance stability.
- Quality Stability Subject Matter Expert (SME) during health authority inspections, client audits, and internal reviews. Author stability protocols, summary reports, and regulatory submission documents.
- Assess stability data, perform statistical analyses (e.g., using Prism or JMP), and evaluate trends to determine product shelf-life and retest periods.
- Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, and stability-related deviations or CAPAs (Corrective and Preventive Actions)
- Coordinate sample testing with CRO, ship test materials and monitor test results.
- Laboratory Equipment maintenance: Schedule all PMs and repairs for QC labs
- Support in sample submissions, receiving, verify, store, shipment of samples, and logbook review.
- Perform other related duties and responsibilities as assigned.
Essential Skills/Experience
- PhD degree preferably in a related science field or equivalent with 0-2 years of relevant CGMP experience; OR Master’s degree preferably in a related science field or equivalent with 2-3 years of relevant CGMP experience; OR Bachelor’s preferably in a related science field or equivalent with 3-5 years of relevant CGMP experience;
- OR Associate’s degree preferably in a related science field or equivalent with 5-7 years of relevant CGMP experience
- Minimum 3 years commercial stability management
- Demonstrated knowledge of regulatory guidance and industry best practices
- Expert knowledge and understanding of stability design, execution and management of long-term, accelerated and in-use stability studies.
- Demonstrated knowledge leading major investigations related to stability, such as LIR, EC, OOT and OOS
- Must demonstrate effective organizational skills and ability to manage multiple projects.
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting and able to adjust workload based upon changing priorities.
Pay and benefits
$101,000 – $151,000 a year
Employer providedWhere can I find out more?
- Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
- Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
- Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
The annual base pay (or hourly rate of compensation) for this position ranges from $100,786 to $151,179. 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.
Qualified retirement programs
Paid time off
Health coverage
Dental coverage
Vision coverage
Short-term incentive bonuses
Where you'll work
Santa Monica, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Santa Monica, CA
From the posting
About AstraZeneca
Date Posted
11-Nov-2026
Closing Date
19-Nov-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.
Equal opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 29% above the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in California5 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $101,000 | — | $151,000 |
| California (middle half) | $123,000 | $126,000 | $174,000 |
| All US (middle half) | $89,000 | $97,500 | $110,000 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 264 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods11
- Collaboration and leadership5
- GMP and compliance3
- Investigations and CAPA3
- Clinical trial conduct3
- Documentation and SOPs2
- Regulatory submissions2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
Company hiring pulse
AstraZeneca on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 9
- Locations
By discipline
- Clinical18 41%
- Quality14 32%
- Regulatory12 27%
By level
- Director26 59%
- Associate & Specialist14 32%
- Senior & Principal2 5%
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Senior Stability Specialist, Quality Control at AstraZeneca
Applications close November 20. $101K–$151K a year, employer provided.