Quality Assurance Specialist

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 positivelyimpact 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 qualitysystem's procedures andassessing 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 ofAstrazeneca. This role is based inTarzana, 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) withinAstraZeneca to assure compliance to the quality manual andmaintain 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 withappropriate partners to manage change controls in a phaseappropriate manner for clinical stage products thatsupports quality risk management (i.e. New Product Introduction, New Facility, & Manufacturing Process Change Controls). 

• Provide ILTtrainings for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control. 

• Work with QA doc control to ensureaccurate 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, equipmentactivation 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, qualitysystems and regulatory

• Experience writing,evaluating and closing investigations,CAPAs and change control records. 

• Adapt best practices for stageappropriate 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 atpace and challenge perceptions.That's why we work, on average, a minimum of three days per week from the office. But thatdoesn't meanwe'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

Closing Date

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.