Quality Assurance Analyst II, Final Product Disposition

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION SUMMARY

The Analyst II, Quality Operations role supports the GMP material receipt and manufacturing processes on the floor by providing Quality Assurance oversight.

The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in in their work scheduling to meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning to the commercial phase.

ESSENTIAL FUNCTIONS

• Performing real time documentation (batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.
• 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, API Starting Material (i.e. Cell Banks, Virus Stock, Bone Marrow) 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.
• Providing Quality Assurance oversight and support issues resolving in manufacturing, facility, equipment, intermediate and final products
• Performing routine quality audits in Manufacturing.
• Reviewing and assessing quality system information (i.e. alarm reports, work orders, environmental reports).
• Supporting quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA.
• Acting as the Quality representative on the floor during manufacturing operations and troubleshooting.
• Investigating non-conformances within warehousing and production areas using knowledge of manufacturing process, utilities, and equipment.
• Participating in cross-functional team meetings to resolve non-conformance and CAPA issues.
• Performing activities related to change controls.
• Cross training within the area of final Batch Record Review and Disposition, drafting and revising SOPs, Work Instructions, and other controlled document types.
• Working independently with moderate supervision and direction.
• Participating in determining objectives of assignments.
• Performing work that consistently requires independent decision-making and the exercise of independent judgment and discretion.
• May conduct other Quality related duties, as assigned.

EDUCATION/EXPERIENCE REQUIREMENT

• Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 2-5 years of experience in a GMP regulated Biologics or Pharmaceutical environment.
• Experience in a commercial phase pharmaceutical environment.

REQUIRED CORE COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Experience with Contract Manufacturing Organizations (preferred).
• Root Cause Analysis Training.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
• Experience in 21 CFR 210/211, 1271 and 810.
• Ability to gown and gain entry to manufacturing areas.
• Flexibility in working schedule, i.e., off hours, second shift, weekend and travel work as required

*All hires are based upon successful completion and passage of a background check.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.