Chemistry Data Reviewer

The Chemistry Data Reviewer plays a key role in Quality Assurance Oversight by reviewing, validating, and approving analytical data generated by QC Chemistry laboratories. This position focuses on ensuring the accuracy, completeness, and compliance of laboratory records, electronic data, and documentation in alignment with regulatory requirements and internal quality standards.

Responsibilities

• Work within the Quality Assurance Oversight team in the Chemistry laboratories and perform detailed technical review of documents and data.

• Review and approve data recorded in laboratory notebooks and Laboratory Information Management System (LIMS) documentation.

• Perform thorough review of test execution, including all sample and standard preparations, instrument setup, and data/result generation.

• Conduct electronic review of chromatography data using Empower software.

• Track review requirements to support the release of finished products, stability samples, and raw material lots.

• Participate in cross-functional teams to assist with closure of chemistry-related investigations.

• Review and draft investigations and risk assessments in support of chemistry quality compliance.

• Perform activities in support of investigations, corrective and preventive actions (CAPAs), and effectiveness checks related to product testing.

• Compile, review, and interpret statistical data and information, and present metrics to stakeholders.

• Perform administrative duties in support of chemistry-related assessments and investigations.

• Benchmark and apply industry best practices to improve processes and data review activities.

• Review, compare, and update current documentation of processes and equipment functionality/design to ensure compliance with FDA 21 CFR Parts 210 and 211., This role is based in a controlled manufacturing facility with a focus on QC Chemistry operations. The Chemistry Data Reviewer primarily performs data review at a desk in an office setting, working closely and collaboratively with QC personnel and other team members. The department consists of approximately eight people, fostering a close-knit, team-oriented environment. While the position is primarily desk-based, there may be occasional visits to the QC testing laboratory, where appropriate lab attire such as a lab coat, lab safety shoes, and safety glasses is required. The work environment emphasizes compliance with GxP and GMP standards, careful handling of chemical data, and consistent interaction with cross-functional quality and laboratory teams.

MUST Have experience with HPLC, Labware LIMS and Empower Software, + Bachelor’s degree in a scientific discipline, such as Chemistry, Biochemistry, or Biology (Chemistry preferred).

• 5+ years of experience using HPLC/UPLC, including method transfer and development, in a pharmaceutical, biotechnology, or medical device environment.

• At least 3 years of experience using Labware LIMS.

• At least 3 years of experience using Empower chromatography software.

• Demonstrated experience with high-volume chemistry data reviews.

• Pharmaceutical industry experience with QC laboratory operations.

• Working knowledge of GxP requirements and their application in a chemistry laboratory setting.

• Strong understanding of GMP principles and FDA 21 CFR Parts 210 and 211.

• Proficiency in data review for chromatography and related analytical techniques.

• Ability to interpret and assess quality investigations, CAPAs, and risk assessments.

Additional Skills & Qualifications

• Hands-on chemistry laboratory experience, including familiarity with analytical instruments and test execution, is preferred.

• Experience with HPLC Empower and Labware LIMS in a QC environment.

• Experience in reviewing method development and validation protocols.

• Exposure to UV-Vis spectroscopy and biochemistry techniques.

• Quality control experience in a regulated manufacturing or laboratory setting.

• Ability to compile, analyze, and present statistical data and quality metrics.

• Strong attention to detail and accuracy in documentation and data review.

• Effective collaboration skills and the ability to work as a team player in cross-functional groups.

• Ability to benchmark and adopt industry best practices to enhance quality and compliance.

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

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.