GeneFab ยท 1 month ago
Senior Specialist, QA Operations
Alameda, CA
Full-time
Onsite
Senior Level
$110K/yr - $135K/yr
5+ years expGeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. The Senior Specialist, Quality Assurance Operations, will provide front line QA support for production operations, ensuring compliance with GMP practices and leading continuous improvement initiatives.
BiotechnologyInterior DesignManufacturing
Responsibilities
Support batch disposition activities, including review of manufacturing batch records, QC test records, audit trails, and assembly of batch release package
Serve as front-line QA for production areas, including partnering with QC, Manufacturing, and Facilities representatives to triage emerging issues, assess impact, and perform immediate mitigating actions
Serve as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances
Identify and lead continuous improvement efforts
Draft, revise, review, and/or approve controlled documents including Standard Operating Procedures
Represent QA on cross-functional project teams and with external partners
Promote Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as adherence to company regulations, policies, SOPs, and guidelines
Identify and anticipate trends in quality issues; collaborate with leadership team to implement quality initiatives
Supports additional work if/as directed by QA leadership
Qualification
Required
Bachelor's degree in life science or related discipline
At least 5 years of experience in QA, QC or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics
Competence in GMP requirements
Able to demonstrate proficiency in Veeva Quality Suite
Excellent verbal and written communication skills
Strong interpersonal skills; able to interact effectively with a variety of internal and external personnel
Proficient in MS Office applications
Preferred
Experience in Cell and Gene Therapy, CDMOs, Qualification/Validation
Company
GeneFab
GeneFab specializes in contract development, manufacturing, and synthetic biology for cell and gene therapies.
51-200 employees
H1B Sponsorship
GeneFab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
Funding
Current Stage
Growth StageLeadership Team
Philip Lee
Chief Executive Officer
Recent News
2025-05-17
Company data provided by crunchbase