Specialist, Quality Systems
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 QA Specialist, Quality Systems. This position will report directly to the Senior Manager, Quality Systems and be responsible for helping build, mature, improve, and maintain the Quality Systems at ImmPACT Bio.
Primary Responsibilities:
- Support activities to maintain a state of control and continuous improvement within the document management, training, Deviation/CAPA, Change control, and other Quality Management systems
- Assist in maintaining and improving the GMP training program
- Support training activities for all Quality Management Systems such as Change Control, Deviations/investigations, and CAPAs.
- Process, file, and archive controlled documents.
- Assist in the preparation and issuance of Manufacturing Batch Records, labels, and logbooks
- Draft, create, and revise SOPs, forms, work instructions, and other controlled documents
- Reconcile paper and electronic QMS records
- Identify and implement continuous improvement projects/actions
- Prepare and distribute training and QMS status reports to ensure compliance and visibility to owners/leadership
- Collaborate with cross-functional teams by providing Quality support as needed
- Support internal audits and regulatory inspections
- Perform other duties, as required
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 with Quality Management Systems (e.g., Deviations, CAPAs, change control 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 with Veeva platforms
- Experience working in cell therapy
- Experience in internal and external audits
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.