ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company’s logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company’s technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA.

ImmPACT Bio is looking for an exceptional individual to join our growing team as Senior Specialist, QA Operations. This position will report directly to the Director, QA Operations and be responsible for on-the-floor quality oversight and lot release activities for incoming materials, drug substance, and final drug product.

Primary Responsibilities:

• Provide on-the-floor QA oversight and support throughout the end-to-end production operations including Chain of Custody/Chain of Identity, assuring current GMP compliance
• Review batch-related documentation and ensure resolution of issues to ensure timely product disposition
• Support disposition of incoming materials and drug substance
• Escalate issues affecting material or product lot production/release to Management in a timely manner
• Ensure approval and timely delivery of Final Product
• Compile and verify all batch related documents into a Final Product lot disposition package
• Perform/assist with quality investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
• Approval of deviations/CAPAs
• Serve as Subject Matter Expert on batch record review and material/product release processes
• Author, revise, review/approve SOPs, Forms, Training materials, and other GMP documentation
• Gather metric information for use in continuous improvement of areas of responsibility, as needed
• Collaborate with a cross-functional team from Manufacturing, Supply Chain, QC, Facilities/Engineering, and other QA functions
• Support and lead cross-functional projects and Quality initiatives
• Coach/Train other QA team members and other functional teams
• Perform other duties, as assigned

Basic Qualifications:

• Bachelors Degree in Sciences or related field and 8+ years’, MS with 6+ years, PhD with 3+ years, or HS with 10+ years experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility or an AA Degree and 9+ years experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Experience in GMP, quality management systems and regulatory requirements (21 CFR Part 11/210/211/600/610), practices/principles
• Knowledge of relevant ICH and FDA guidance documents
• Experience in batch record review and material/product release activities
• Experience with Quality Management Systems (e.g., Deviations, CAPAs, change control etc.)
• Knowledge and experience of aseptic manufacturing processes
• Ability to work in controlled & classified cleanroom environment requiring donning of cleanroom garments (e.g., gowns, gloves, booties, hoods/masks, etc.)
• Proficient in MS Word, Excel, Power Point and other applications
• Strong communication (verbal and written) and interpersonal skills
• Ability to communicate and work independently with scientific/technical personnel
• Ability to work in a fast-paced small company environment with minimal supervision/direction
• Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
• Ability to work weekends, as needed

Preferred Qualifications:

• Experience in cell therapy manufacturing
• Experience with information electronics systems (e.g., LIMS, MES, Veeva, Oracle EBS)
• Experience in internal and external audits
• Experience with Validation practices/principles + Knowledge of IQ/OQ/PQ

Worksite Location:

• Onsite in West Hills, CA

Work Schedule:

• or

Travel Requirements:

• Willingness to travel domestically or internationally up to 15% of the time

Duration:

• Contract-to-hire

ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.