Specialist, Quality

4 days ago

Santa Monica, United States Neogene Therapeutics Full time

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 passion 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 Neogene. This role is based in Santa Monica, CA, and reports to the Sr 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 Neogene 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 on-time 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

MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required, or alternatively, a BA/BS with 2+ years, an Associate's degree with 4+ years, or a High School diploma with 5+ years of Quality Assurance or GMP experience. Knowledge of and ability to apply GMP in conformance to US standards. 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.

 

When we put unexpected teams in the same room, we fuel bold 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.

 

The annual base salary for this position ranges from $68,822 to $86,027. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

 

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.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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