Senior Specialist, Quality Assurance Operations
22 hours ago
ImmPACT Bio is seeking a highly skilled Senior Specialist, Quality Assurance Operations to join our team. As a key member of our QA Operations team, you will be responsible for ensuring the quality and integrity of our products throughout the entire production process.
Key Responsibilities- Provide on-the-floor quality oversight and support to ensure compliance with current Good Manufacturing Practices (cGMP)
- Review batch-related documentation and ensure timely resolution of issues to ensure product disposition
- Support the 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 quality investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
- Approve deviations/CAPAs
- Serve as a subject matter expert on batch record review and material/product release processes
- Author, revise, review, and 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
- Bachelor's degree in sciences or related field and 8+ 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 and classified cleanroom environments requiring donning of cleanroom garments (e.g., gowns, gloves, booties, hoods/masks, etc.)
- Proficient in MS Word, Excel, PowerPoint, 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
- 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 and knowledge of IQ/OQ/PQ
Onsite in West Hills, CA
Travel RequirementsWillingness to travel domestically or internationally up to 15% of the time
DurationContract-to-hire
CompensationSalary range: $60-$74 USD
ImmPACT Bio provides a generous total rewards package, including 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.
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