Senior Specialist, QA Operations

GeneFab • Alameda, CA

12d • $110,000 - $135,000

About The Position

The Senior Specialist, Quality Assurance Operations, is an integral part of the team supporting QA Operations at the new Alameda cell therapy manufacturing facility. This role will provide front line QA support for production operations including manufacturing and quality control, requiring strong GMP and problem-solving skills, prior hands-on experience in QC or manufacturing, and an agile, continuous improvement mindset.

Requirements

• 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
• Experience in Cell and Gene Therapy, CDMOs, Qualification/Validation
• Able to demonstrateproficiency 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees