Quality Assurance Specialist

Russell Tobin is seeking a Quality Assurance Specialist for a clinical-stage cell therapy company, that develops T cell reprogramming technologies for patients with solid tumors.Job Title: Quality Assurance SpecialistLocation: West Hills, CA 91304 (on-site)Job Type: ContractLength: 6-MonthsHours: Tuesday - Saturday from 8 AM -5 PMPay Rate: $34.00 - $38.98 per hourDuties: The incumbent is responsible for the continued implementation and operation of Quality Assurance processes. This role will oversee Asset Management, Batch Records, Change Management, Deviation and CAPA, GMP Cleanroom Support, Lot Disposition, Quality Control (QC) Data, Quality Risk Management (QRM), Raw MaterialsResponsibilities:Implementation of GMP Quality OperationsCollaborate with key stakeholders and system owners on the continuous improvement of the Quality GMP processes at West Hills. Create and/or collaborate on corresponding SOPs.Represent Quality Assurance on project specific teams, as needed.Perform review and approval of executed batch records, and resolution of discrepancies with manufacturing personnel.Perform review and approval of Change Management deliverables.Perform review and approval of Deviation and CAPA record deliverables.Provide quality support for manufacturing operations in the cleanroom facilities (e.g., changeover/line clearance support, APH receipt, product pack-out, event triage).Perform review of final product lot file and lot disposition.Participate in QRM activities (e.g., serve as Quality representative for risk assessments)Perform review and disposition of incoming raw materials, and approval of raw material specifications.Author and/or collaborate on the creation and revision of Standard Operating Procedures across the West Hills site.Support other routine Quality operations as required, commensurate with experience and the West Hills site maturation.Education: BSc degree with 7 years' experience in biology, biochemistry, chemical engineering, bioengineering, or related technological fieldMSc degree with 4 years' experience in biology, biochemistry, chemical engineering, bioengineering, or related technological fieldRequirements:A minimum of 6 years in GMP biopharmaceutical operations with a minimum of 4+ years in a GMP Quality role.Experience in clinical manufacturing.Experience with quality management systems (e.g. deviations, CAPAs, change management).Knowledge, Skills, and Abilities: Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.The desire and ability to work in a fast-paced, start-up environment.Motivated and organized critical thinker with solid interpersonal and business communication skills.Demonstrated ability to work effectively with a team to set goals, develop sound project plans, monitor progress, and report results.Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.Excellent analytical skills and scientific/technical expertise.Benefits that Russell Tobin offers:Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors. Apply Today! If you are interested in the position, please email your resume to rob.vanriet@ for immediate consideration.

Created: 2025-02-19