Senior Specialist, Quality Assurance Operations
5 hours ago
At ImmPACT Bio, we are seeking a highly skilled Senior Specialist, Quality Assurance Operations to join our team. This role will be responsible for providing on-the-floor quality oversight and support throughout the end-to-end production operations, ensuring current GMP compliance.
Key Responsibilities:- Provide quality oversight and support throughout production operations
- Review batch-related documentation and ensure timely product disposition
- Support disposition of incoming materials and drug substance
- Escalate issues affecting material or product lot production/release to Management
- Ensure approval and timely delivery of Final Product
- Compile and verify 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
- Approve 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 continuous improvement of areas of responsibility
- Collaborate with cross-functional teams 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 functional teams
- Bachelor's 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
- Experience in GMP, quality management systems, and regulatory requirements (21 CFR Part 11/210/211/600/610)
- 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)
- Knowledge and experience of aseptic manufacturing processes
- Ability to work in controlled & classified cleanroom environment requiring donning of cleanroom garments
- Proficient in MS Word, Excel, Power Point, and other applications
- Strong communication 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
- 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 Requirements:Willingness to travel domestically or internationally up to 15% of the time
Compensation: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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