Our Client, a Clinical-Stage Cell Therapy company, is looking for a Specialist, Quality Assurance for their West Hills, CA location. Responsibilities: + Implementation of GMP Quality Operations + Collaborate 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. Requirements: + 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). + 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. + The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. + BSc degree with 7 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field + MSc degree with 4 years’ experience in biology, biochemistry, chemical engineering, bioengineering, or related technological field + SOP + Batch Record + Workflow + GMP + Quality Assurance + Biopharmaceutical + Bioengineering + Change Management + Cleanroom + Sterile + Visual Inspection + Biochemistry + Batch Records + Fast Learner + Risk Management + Risk Assessments + Trading + SOPS + Asset Management + Manufacturing Operations + GMP Processes + Corrective And Preventive Action + Quality Control + Minimum Degree Required: Bachelor's Degree Why Should You Apply? + Health Benefits + Referral Program + Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.