Senior Specialist, Quality Assurance Operations
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
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:
- Bachelor's Degree in Sciences or related field and 5+ 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
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
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.