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Gmp Data Reviewer Jobs (NOW HIRING)

Lonza

MES Engineer Level 2

Portsmouth, NH · On-site

Process automation systems, perform PI data analysis, review CIP/SIP circuits and flow paths, and support system testing, change controls, and quality investigations (CAPA, RCA, deviations). Use GMP ...

Alexza

QC Technical Resources Scientist I

Fremont, CA · On-site

$120K/yr

Ensure timely pull points, testing, data review, and reporting for all stability studies. * Trend ... Familiarity with GMP, data integrity principles, and regulatory expectations. * Strong ...

Lonza

MES Engineer Level 2

Portsmouth, NH

Process automation systems, perform PI data analysis, review CIP/SIP circuits and flow paths, and support system testing, change controls, and quality investigations (CAPA, RCA, deviations). Use GMP ...

Global Channel Management, Inc.

Tech Writer

Andover, MA · On-site

$45/hr

GMP data verification experience; experience working with documentatum system for controlled ... Execute and coordinate necessary documentum workflow activities for the authoring, review, and ...

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Gmp Data Reviewer information

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How much do gmp data reviewer jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for gmp data reviewer in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $14.42 and $36.30 per hour, depending on experience, location, and employer.

What are some common challenges faced by GMP Data Reviewers during the documentation review process?

GMP Data Reviewers often encounter challenges such as inconsistent data entries, incomplete documentation, and discrepancies that require clarification with laboratory or production staff. Managing tight deadlines while ensuring compliance with regulatory standards can also be demanding. Effective communication with cross-functional teams is essential for resolving issues quickly and maintaining data integrity, making attention to detail and strong organizational skills crucial for success in this role.

What are the key skills and qualifications needed to thrive as a GMP Data Reviewer, and why are they important?

To thrive as a GMP Data Reviewer, you need a solid understanding of Good Manufacturing Practices, analytical techniques, and a relevant science degree or equivalent experience. Familiarity with laboratory information management systems (LIMS), chromatography data systems, and knowledge of regulatory documentation standards is essential. Attention to detail, critical thinking, and effective communication are vital soft skills for identifying discrepancies and ensuring compliance. These competencies are crucial to maintain data integrity and regulatory compliance in pharmaceutical manufacturing processes.

What are GMP Data Reviewers?

GMP Data Reviewers are professionals responsible for reviewing and verifying data generated in Good Manufacturing Practice (GMP) environments, typically within the pharmaceutical, biotechnology, or medical device industries. Their main role is to ensure that all laboratory and manufacturing records comply with regulatory and quality standards, such as those set by the FDA or EMA. They meticulously check documentation for accuracy, completeness, and adherence to protocols to support product quality and regulatory compliance. GMP Data Reviewers often collaborate with laboratory analysts, quality assurance teams, and regulatory affairs to resolve discrepancies and maintain data integrity.
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Infographic showing various Gmp Data Reviewer job openings in the United States as of May 2026, with employment types broken down into 88% Full Time, 6% Temporary, and 6% Contract. Highlights an 100% In-person job distribution, with an average salary of $54,583 per year, or $26.2 per hour.

QC Specialist (Data Review & Investigations)

GeneFab

Alameda, CA

$80K - $120K/yr

Full-time

Posted 18 days ago

Job 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.

Key Responsibilities - Data Review & Documentation

  • 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. 

Key Responsibilities - Investigations & Deviations:

  • 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. 

Education and Experience:

  • 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. 

$80,000 - $120,000 a year
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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