Senior Specialist, QA Operations
Alameda, CA
Quality Assurance /
Contract /
On-site
We are seeking a dynamic and hands-on Senior Specialist to join our Quality team at our new Alameda cell therapy manufacturing facility. In this fast-paced, collaborative CDMO environment, you’ll be a key quality partner providing front-line support to both manufacturing and quality control (QC) teams. This role is ideal for an experienced quality professional with strong technical judgment, a continuous improvement mindset, and the confidence to engage with clients and cross-functional stakeholders.
Key Responsibilities
- Provide QA oversight of both manufacturing and QC analytical operations, including review and approval of batch records, QC test records, and associated investigations
- Partner with QC and manufacturing teams to triage floor issues in real time, lead or support impact assessments, and ensure appropriate immediate actions are taken
- Serve as QA reviewer and approver for deviations, CAPAs, OOS investigations, and non-conformances, with a focus on root cause analysis and timely closure
- Act as the primary QA point of contact for weekly client interactions, addressing inquiries, supporting audit readiness, and presenting documentation related to batch disposition and investigations
- Represent QA on cross-functional and client-facing project teams, contributing quality expertise to process improvements, technical transfers, and operational readiness efforts
- Identify trends or recurring issues and contribute to quality system enhancements or procedural improvements
- Draft, review, and/or approve GMP documentation, including SOPs, protocols, reports, and logbooks
- Promote a culture of compliance, right-first-time execution, and continuous learning in alignment with cGMP expectations and internal policies
Qualifications
- Bachelor's degree in a life sciences or related discipline required
- Minimum 5 years of experience in QA, QC, or Manufacturing within a GMP-regulated biopharma environment; prior experience supporting QC analytical testing or investigations is required
- Experience in cell and gene therapy, CDMOs, and/or startup biotech strongly preferred
- Solid understanding of FDA and EU GMPs, and experience supporting batch disposition activities
- Strong verbal and written communication skills, with the ability to interact confidently with internal teams and external clients
- Proficiency in MS Office; experience with electronic quality systems such as Veeva and LIMS is a plus
- Proven ability to work independently, prioritize effectively, and drive results in a fast-paced environment
Compensation
- The base annual compensation range for this role is $105,000- $125,000 (Specialist level) ; 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.
