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The Senior Specialist, QA Operations role at Genefab is an on-site position located in Alameda, CA.

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Senior Specialist, QA Operations

GenefabAlameda, CA4w ago

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.

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

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

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

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.

Senior Specialist, QA Operations

Responsibilities:

Qualifications:

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