QA Specialist, Quality Operations

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The QA Specialist, Quality Operations (QAO) role is an individual contributor that guides and supports the GMP material receipt and manufacturing process on the floor by providing Quality Assurance oversight. The position will be focused on day-to-day support of manufacturing operations, and quality review and disposition of documents associated with raw materials and manufactured products. Essential Functions Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures in support of disposition of manufactured product. Document, manage and support issue resolution associated with batch review. Perform inspection and release of incoming raw materials according to appropriate material specifications and standard operating procedures. Perform Quality Assurance activities to support Manufacturing operations, including but not limited to product label issuance/reconciliation, batch record issuance, Starting Material (i.e. Cell Banks) Receipt, Release and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management. Perform Product Complaint Investigations to determine root cause and identify/implement related Corrective and Preventative Actions. Initiate Quality Deviation and perform robust investigation to determine root cause and identify/implement related Corrective and Preventative Actions. Initiate and Own Quality Change Control, complete associated implementation task assignments and provide supporting documentation for completion of change records. Perform Manufacturing Floor Observations (including Practice vs. Procedures, Aseptic Technique and Media Fill Observations) to ensure inspection readiness. Identify Continuous Improvement Activities and implement changes to enhance the overall Quality Systems, Procedures and Oversight of GMP Operations. Support both Internal and External Compliance/Regulatory Audits. Maintain compliance with all assigned training requirements and train others as assigned. Create, Draft and/or revise SOPs, Work Instructions, and other controlled document types, as assigned. Collaborate in cross-functional team meetings to resolve quality issues. Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree in engineering, biological science, chemistry, or related science field with 5+ years of experience in the pharmaceutical / biopharmaceutical industry is required; OR Bachelor's degree in engineering, biological science, chemistry, or related science field with 4+ years of experience with ImmunityBio manufacturing organization required. Experience of biologics cGMP manufacturing includes ideally recombinant protein and cell therapy cGMP manufacturing required. Strong understanding of and experience working with quality management systems required. 2+ years of direct experience in Quality Assurance / Quality Control preferred. Knowledge, Skills, & Abilities Strong verbal, written, and interpersonal communication skills. Proficiency in computer use and Microsoft Office applications. Proven ability to work independently to analyze and resolve issues that impact quality. Attention to detail with strong analytical and problem solving skills. Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities. Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and dead