Quality Assurance Specialist

GTT•Tarzana, CA

8d•Onsite

About The Position

At the client's Oncology R&D division, they follow the science to explore and innovate, working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. The organization has the potential to grow its pipeline and positively impact the lives of billions of patients around the world, committed to making a difference and building its business around a passion for science — now fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. The Specialist, Quality ensures compliance with the quality system's procedures and assessments. This unique role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of the client. This role is based in Tarzana, CA, and reports to the Manager, QA.

Requirements

Knowledge of and ability to apply GMP in conformance with US standards.
Proficient in cGMP regulations, quality systems, and regulatory requirements.
Experience writing, evaluating, and closing investigations, CAPAs, and change control.
Adapt best practices for stage-appropriate products.
MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required, or 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.
2–4 years of Cell Therapy Experience.

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 the organization to ensure compliance with 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 support quality risk management (i.e., New Product Introduction, New Facility, & Manufacturing Process Change Controls).
Provide ILT training for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, and 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 products 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 the quality release of raw materials used for manufacturing and quality control testing.