Chemistry Data Reviewer

Job Title:

Chemistry Data Reviewer Job Description The Chemistry Data Reviewer plays a key role in ensuring the accuracy, integrity, and compliance of analytical chemistry data generated by quality control laboratories. This position focuses on reviewing and validating laboratory data, including high-volume and complex HPLC and wet chemistry testing, to support the release of finished products, stability studies, and raw materials. The role requires strong hands-on analytical chemistry experience, deep familiarity with HPLC and related software systems, method development and validation and a solid understanding of GxP and FDA regulations. Responsibilities Review and validate chemistry data in laboratory notebooks, data printouts, lab test requests, assessments, reports, investigations, controlled data sheets, and associated electronic records and audit trails generated by QC Chemistry laboratories. Work within the Quality Assurance Oversight team to perform detailed technical review of laboratory documents and records. Review and approve data in accordance with laboratory notebook entries and LIMS documentation, ensuring proper execution of tests, including preparations, instrument setup, and data and result generation. Perform electronic review of chromatography data using Empower software to verify accuracy, completeness, and compliance. Track data review requirements to support the timely release of finished products, stability samples, and raw material lots. Participate in cross-functional teams to support the closure of chemistry-related investigations and ensure appropriate documentation. Review and draft investigations and risk assessments related to chemistry quality compliance, ensuring alignment with internal procedures and regulatory expectations. Support investigations, CAPAs, and effectiveness checks related to product testing and laboratory data. Compile, review, interpret, and present statistical data and metrics related to laboratory performance and data review activities. Perform administrative duties to support chemistry-related assessments, investigations, and documentation control. Benchmark and apply industry best practices in laboratory data review, quality oversight, and documentation. Review, compare, and update documentation for processes and equipment functionality and design to ensure compliance with

FDA 21 CFR

Parts 210 and 211. Progress from reviewing high-volume, simpler tests to more complex testing as training advances, including wet chemistry tests such as titrations, limit testing, and pH testing, as well as HPLC analyses. Collaborate closely with QC laboratory staff and other stakeholders to resolve data discrepancies, clarify test results, and maintain high standards of data quality. Adhere to GxP requirements and internal SOPs throughout all data review and documentation activities. Essential Skills Bachelor's degree in a scientific discipline, preferably Chemistry; Biochemistry or Biology may also be considered. 3-5 years of hands-on analytical chemistry experience using HPLC or UPLC in a pharmaceutical, biotechnology, or medical device environment. Experience with method transfer and development using

HPLC/UPLC.

Practical experience performing analytical chemistry testing, including HPLC and wet chemistry techniques. Experience working with Empower software for chromatography data review. Experience working with LIMS, preferably LabWare LIMS, for sample and data management. Working knowledge of GxP requirements and quality control laboratory practices. Strong accuracy and attention to detail when reviewing technical data and documentation. Well-developed analytical and problem-solving skills, with the ability to use reasoning to resolve issues. Strong oral and written communication skills, with the ability to compose clear, concise messages and interact effectively with cross-functional teams. Ability to make sound decisions and determine appropriate courses of action when addressing data and quality issues. Organizational skills with the ability to follow systematic methods and manage multiple review tasks. Ability to interpret and apply FDA regulations, particularly 21 CFR Parts 210 and 211, to laboratory documentation and processes. Customer-oriented mindset with the ability to support internal stakeholders while adhering to procedures. Ability to work both independently and collaboratively as part of a team-focused environment. Additional Skills & Qualifications Hands-on chemistry laboratory experience beyond data review, including wet chemistry techniques such as titrations, limit testing, and pH testing. Familiarity with FTIR, UV-Vis, IR, and other analytical instrumentation used in QC laboratories. Experience reviewing method development and validation protocols. Experience in biochemistry or related analytical techniques is beneficial. Prior exposure to quality investigations, CAPAs, risk assessments, and effectiveness checks. Experience compiling and presenting metrics and statistical data related to laboratory performance. Conceptual thinking skills with the ability to understand abstract concepts and complex testing strategies. Ability to benchmark and incorporate industry best practices into existing processes. Team-oriented, personable approach with a strong focus on collaboration and supporting QC operations. Work Environment This role is based within a controlled laboratory and manufacturing facility, with the primary work performed at a desk in an office setting dedicated to data review. The Chemistry Data Reviewer works closely and collaboratively with QC staff and the Quality Assurance Oversight team, typically within a group of approximately eight colleagues. While the majority of the work involves reviewing data at a computer, there may be occasional need to enter QC testing areas, where appropriate laboratory attire such as a lab coat, safety shoes, and safety glasses is required. The environment follows GxP and FDA-compliant procedures, with access to technologies such as

HPLC/UPLC

systems, Empower chromatography software, LabWare LIMS, FTIR, UV-Vis, and other analytical instruments. New team members receive structured training during the first few weeks, including SOP readings, partnering with a GMP trainer, and a phased approach from simple wet chemistry tests to more complex, high-volume testing. The setting supports a collaborative, team-oriented culture focused on quality, compliance, and continuous improvement. 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 May 16, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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.