QC Specialist (Data Review & Investigations)

United States·AlamedaFull-timemid

OtherQc Specialist

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Requirements Summary

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-functio

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OtherQc Specialist

The QC Specialist (Data Review & Investigations) is responsible for supporting Quality Control laboratory operations through comprehensive data review, laboratory investigations, deviation management, and GMP documentation activities in a Cell & Gene Therapy environment. This role ensures laboratory testing, data integrity, and documentation comply with current GMP regulations, internal procedures, and regulatory expectations.

The individual will work cross-functionally with QC, QA, Manufacturing, MSAT, and Validation teams to support clinical and commercial manufacturing activities.

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 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.