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# QC Specialist (Data Review & Investigations)

- **Company:** Genefab, Llc
- **Location:** Alameda, CA, United States
- **Experience:** Experienced
- **Salary:** $80,000.0 - $120,000.0
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Lasttests
- **Published:** May 23, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=8f875c5a4c37d91d

## About the Role

Do you have experience in Production deviation management?, Do you have a Bachelor's degree?, * 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.

## Description

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., * 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.


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