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Gmp Data Reviewer Jobs (NOW HIRING)

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 ...

Actalent

QA Reviewer I

Vernon Hills, IL

$23 - $25/hr

Familiarity with GMP documentation practices (Good Documentation Practices, GDP). * Ability to perform detailed data review and verification of laboratory results against Certificates of Analysis ...

Integrated Resources INC

QC Microbiologist

Andover, MA

$25.75 - $34/hr

Position 1: This role will be responsible for the review of GMP documentation respective to QC Microbiology assay and activities. Review will include: Environmental monitoring, water data including ...

Vrtx

Manager GMP Quality Operations

Boston, MA

$118K - $177K/yr

The GMP Quality Operations Manager is recognized internally as an expert in the principles and ... review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and ...

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How much do gmp data reviewer jobs pay per hour?

As of Jun 14, 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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Gmp Data Reviewer jobs near you
Infographic showing various Gmp Data Reviewer job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $54,583 per year, or $26.2 per hour.

QC Technical Resources Scientist I

Nova Pneuma, Inc.

Fremont, CA

$120K/yr

Full-time

Posted 19 days ago

Job description

Job Summary

Provides scientific, technical, and operational support to the Quality Control organization while coordinating all aspects of the site’s stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers, verifications, and qualifications activities.

Responsibilities

  • Develop and maintain stability protocols, reports, and other related documentation to support the stability program.
  • Manage stability chambers, including qualification, monitoring, and capacity planning.
  • Ensure timely pull points, testing, data review, and reporting for all stability studies.
  • Trend stability data, identify OOT/OOS signals, and support investigation related to stability samples
  • Author, review, and revise QC SOPs, test methods, and technical documentation
  • Document and maintain risk assessment reports in accordance with quality standards
  • Conduct or participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis and implementing Corrective/Preventive Actions (CAPA).
  • Author, review, and approve technical documents, SOPs, and reports, ensuring adherence to FDA/EMA and cGMP regulations.
  • Develop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC.
  • Train and mentor junior analysts, and interface with clients or regulatory authorities.

Skills required

  • Deep knowledge of GMP regulations and advanced laboratory techniques.
  • Strong Knowledge of in Empower and OpenLab chromatography software.
  • Strong understanding of stability program requirements (ICH Q1A–Q1E).
  • Familiarity with GMP, data integrity principles, and regulatory expectations.
  • Strong organizational skills and ability to manage multiple studies and timelines.
  • Excellent documentation, communication, and cross-functional collaboration abilities.
  • Knowledge of method validation or lifecycle management.
  • Ability to analyze data trends and contribute to technical investigations.
  • Familiarity with regulatory guidelines (ICH, FDA, EMA)
  • Maintain audit‑ready documentation and support internal and external inspections.
  • Well-organized, capable of multi-tasking and working on complex problems with sound scientific judgement
  • Excellent data analysis skills with attention to detail and interpretation of results
  • Excellent written and oral communication skills
  • Experience with computer software such as WORD, EXCEL and chromatographic workstation systems

Education and experience

  • BS in Chemistry, Biochemistry, Analytical Chemistry or related field
  • Minimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotech

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • Potentially prolonged periods standing
  • Must be able to lift up to 15 pounds at times

Compensation:

The base salary for this role starts at $120,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and a discretionary annual target bonus for full-time positions.