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., * 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.

Teamwork Chemistry Visionary Operations Innovation Statistics Biochemistry Spectroscopy Investigation Team Oriented Risk Analysis Biotechnology Collaboration Chromatography Pharmaceuticals Detail Oriented Medical Devices Quality Assurance Laboratory Safety Method Development Process Improvement Test Execution Engine Laboratory Experience Scientific Instruments Artificial Intelligence LabWare LIMS (Software) Administrative Functions Software Technical Review Engineering Design Process Good Manufacturing Practices Empower 3 Chromatography Software High-Performance Liquid Chromatography Corrective And Preventive Action (CAPA) Laboratory Information Management Systems, * 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., * 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., HVAC Voltage Machinery Visionary Leadership Automation Innovation Hand Tools Electricity Electronics Low Voltage Prototyping Sheet Metal Blueprinting High Voltage Web Browsers Test Planning Cable Routing Test Equipment Energy Systems Detail Oriented Microsoft Excel Lifting Ability Problem Solving English Language Microsoft Office Microsoft Outlook Electrical Wiring Polyvinyl Chloride Mechanical Drawings Mechanical Assembly Performance Testing Power Tool Operation Brazing (Metal Work) Preventive Maintenance Electrical Engineering New Product Development Artificial Intelligence Technical Communication Automatic Test Equipment Ability To Meet Deadlines Engineering Design Process Portable Appliance Testing Verbal Communication Skills Interpersonal Communications Troubleshooting (Problem Solving) Electrical/Electronic Troubleshooting, Corona, CA*On-Site AutoCAD LabVIEW Marketing Operations Innovation Resilience 3D Modeling Natural Gas Data Centers Blueprinting Communication Test Planning Test Equipment Experimentation Design Software Vertical Market Tensile Testing Microsoft Office Data Acquisition Test Engineering Failure Analysis SolidWorks (CAD) Renewable Energy Telecommunications Laboratory Testing Electrical Systems Laboratory Equipment Training And Development ASTM International Standards Ethical Standards And Conduct Programmable Logic Controllers Troubleshooting (Problem Solving), Invoice Review Microsoft Excel Customer Service Microsoft Office Safety Standards Brand Management Microsoft Outlook Business Continuity Logistics Management Organizational Skills Packaging And Labeling Intellectual Curiosity

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

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