About this role
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.
• Perform detailed reviews of analytical and microbiological laboratory data for accuracy, completeness, compliance, and data integrity. • Review laboratory notebooks, worksheets, electronic records, chromatographic data, calculations, and supporting documentation. • Ensure compliance with cGMP, GDP, ALCOA+, and internal procedures. • Support review and approval of: • • Raw Materials data • • In-process testing • • Release testing • • Stability testing • • Method transfer documentation • • Qualification and validation protocols/reports • Verify laboratory investigations, deviations, and OOS/OOT documentation are scientifically sound and properly documented. • Support batch disposition activities through timely QC documentation review.
• Lead and/or support laboratory investigations including: • • OOS (Out of Specification) • • OOT (Out of Trend) • • Deviations • • Invalid Assays • • Atypical Results • • CAPAs • Conduct root cause analysis using scientific and risk-based approaches. • Collaborate with cross-functional teams to identify corrective and preventive actions. • Track investigation timelines and ensure closure within established metrics. • Support implementation and effectiveness checks of CAPAs.
• Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Biotechnology, or related scientific discipline. Advanced degree is a plus. • Minimum 3–5 years of GMP Quality Control experience in biotechnology, pharmaceutical, or Cell & Gene Therapy industry. • Experience with laboratory investigations, deviation management, and GMP data review required. • Experience supporting clinical and/or commercial manufacturing environments preferred. • Familiarity with Cell & Gene Therapy processes and aseptic manufacturing preferred. • Strong attention to detail and organizational skills. • Excellent written and verbal communication skills. • Ability to work in a fast-paced GMP environment. • Strong collaboration and teamwork mindset. • Ability to prioritize multiple assignments and meet timelines. • Problem-solving and critical-thinking capabilities.
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.
• Perform detailed reviews of analytical and microbiological laboratory data for accuracy, completeness, compliance, and data integrity. • Review laboratory notebooks, worksheets, electronic records, chromatographic data, calculations, and supporting documentation. • Ensure compliance with cGMP, GDP, ALCOA+, and internal procedures. • Support review and approval of: • • Raw Materials data • • In-process testing • • Release testing • • Stability testing • • Method transfer documentation • • Qualification and validation protocols/reports • Verify laboratory investigations, deviations, and OOS/OOT documentation are scientifically sound and properly documented. • Support batch disposition activities through timely QC documentation review.
• Lead and/or support laboratory investigations including: • • OOS (Out of Specification) • • OOT (Out of Trend) • • Deviations • • Invalid Assays • • Atypical Results • • CAPAs • Conduct root cause analysis using scientific and risk-based approaches. • Collaborate with cross-functional teams to identify corrective and preventive actions. • Track investigation timelines and ensure closure within established metrics. • Support implementation and effectiveness checks of CAPAs.
• Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Biotechnology, or related scientific discipline. Advanced degree is a plus. • Minimum 3–5 years of GMP Quality Control experience in biotechnology, pharmaceutical, or Cell & Gene Therapy industry. • Experience with laboratory investigations, deviation management, and GMP data review required. • Experience supporting clinical and/or commercial manufacturing environments preferred. • Familiarity with Cell & Gene Therapy processes and aseptic manufacturing preferred. • Strong attention to detail and organizational skills. • Excellent written and verbal communication skills. • Ability to work in a fast-paced GMP environment. • Strong collaboration and teamwork mindset. • Ability to prioritize multiple assignments and meet timelines. • Problem-solving and critical-thinking capabilities.
About GeneFab
GeneFab is hiring for the qc specialist role. NewJob aggregates active openings directly from GeneFab's applicant tracking system, so this listing is current.
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