Chemistry Data Reviewer

Job Title: Chemistry Data Reviewer

Job Description

The Chemistry Data Reviewer supports quality assurance oversight for QC Chemistry laboratories by thoroughly reviewing and validating laboratory data. This role focuses on ensuring the accuracy, completeness, and compliance of data generated in support of finished products, stability studies, and raw material testing. The position requires strong technical expertise in chromatography, laboratory information management systems, and regulatory expectations to maintain high standards of data integrity and chemistry quality compliance.

Responsibilities

• Work within the Quality Assurance Oversight team supporting the Chemistry laboratories and perform detailed technical review of laboratory documentation.
• Review and approve data recorded in laboratory notebooks and in the Laboratory Information Management System (LIMS), ensuring consistency between source data and LIMS entries.
• Conduct thorough review of test execution, including sample and solution preparations, instrument setup, method parameters, and data/result generation.
• Perform electronic review of chromatographic data using Empower software, ensuring compliance with methods, specifications, and data integrity requirements.
• Track and manage data review requirements to support the release of finished products, stability samples, and raw material lots.
• Participate in cross-functional teams to assist in the closure of chemistry-related investigations and support timely resolution of issues.
• Review and draft investigations and risk assessments related to chemistry quality compliance, ensuring clear documentation and appropriate corrective actions.
• Support investigations, corrective and preventive actions (CAPAs), and effectiveness checks associated with product testing and chemistry data.
• Compile, review, and interpret statistical data and information, and present metrics that support quality oversight and continuous improvement.
• Perform administrative tasks in support of chemistry-related assessments, investigations, and documentation control.
• Benchmark and apply industry best practices to strengthen chemistry data review processes and quality oversight.
• Review, compare, and update current documentation for processes and equipment functionality/design to ensure compliance with FDA 21 CFR Parts 210 and 211.
• Collaborate closely with QC personnel and other stakeholders to resolve data queries and maintain clear communication regarding testing and data review.

Essential Skills

• Bachelor's degree in a scientific discipline, such as Chemistry (preferred), Biochemistry, or Biology.
• 3-5 years of experience using HPLC/UPLC, including method transfer and development experience in a pharmaceutical, biotechnology, or medical device company.
• At least 3 years of experience using Labware LIMS in a QC or GxP environment.
• Hands-on experience with high-volume chemistry data reviews in a regulated laboratory setting.
• Practical experience working in a chemistry laboratory with a working knowledge of GxP requirements.
• Proficiency with HPLC and UPLC systems, including chromatographic data acquisition and analysis.
• Experience using Empower software for electronic chromatography data review.
• Knowledge of FDA regulations, particularly 21 CFR Parts 210 and 211, and their application to laboratory processes and documentation.
• Strong understanding of data integrity principles and quality control practices in a laboratory environment.
• Ability to review, interpret, and validate laboratory data, test methods, and reports with high attention to detail.
• Experience with quality investigations, CAPAs, and effectiveness checks related to product testing.
• Ability to compile, review, and interpret statistical data and present quality metrics.
• Effective communication skills for collaborating with QC and cross-functional teams.
• Strong organizational skills to manage multiple data reviews and documentation requirements.

Additional Skills & Qualifications

• Experience reviewing method development and validation protocols.
• Familiarity with UV-Vis spectroscopy and biochemistry-related analytical techniques.
• Experience with Labware LIMS or similar laboratory information management systems.
• Experience in quality control within pharmaceutical, biotechnology, or medical device industries.
• Exposure to high-throughput QC environments handling large volumes of chemistry data.
• Ability to benchmark and implement industry best practices in quality and data review.
• Comfort working with electronic data, audit trails, and controlled data sheets.
• Strong documentation skills for drafting investigations, risk assessments, and process updates.
• Team-oriented mindset and personable approach when working closely with QC and other colleagues.

Work Environment

This role operates within a controlled laboratory and manufacturing facility environment, with primary duties performed at a desk in an office setting dedicated to data review. The Chemistry Data Reviewer works closely and collaboratively with QC personnel and other team members, with approximately eight people in the department, fostering a supportive and team-oriented culture. Although the primary focus is on desk-based data review, the role may occasionally require visits to the QC testing laboratory, where work takes place around chemicals and analytical equipment. Appropriate laboratory attire, such as a lab coat, lab safety shoes, and safety glasses, is used when entering the lab areas. The position involves working with computer systems, LIMS, and chromatography software throughout the day in a structured, regulated environment that emphasizes quality, compliance, and collaboration.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $40.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Jul 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.