Specialist/Senior Specialist, Quality Assurance Operations

The Specialist or 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.

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
  
  
  

Qualifications:

• 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; Veeva Quality Suite a plus
• 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
  
  
  

Salary and Benefits:

• The base annual compensation range for this role is $90,000.00 - $100,000 (Specialist level) and $100,000- $120,000 (Sr. Specialist); starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
  
  
  

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.