Job Title: Analytical Data ReviewerJob Description As an Analytical Data Reviewer, you will be responsible for developing and maintaining critical documentation related to Quality Control and Analytical Development. This includes writing, editing, and updating Standard Operating Procedures, test methods, specifications, and protocols. You will ensure all documentation is consistent, clear, and compliant with regulatory guidelines, while maintaining accurate version control and document tracking. Responsibilities + Write, edit, and maintain Standard Operating Procedures (SOPs), test methods, specifications, work instructions, and protocols related to Quality Control and Analytical Development. + Develop and update analytical test reports, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method validation protocol/reports, method transfer protocol/reports, and technical documents including change controls, deviations, CAPAs, and OOS investigations. + Ensure consistency, clarity, and compliance in all documentation. + Maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases. + Ensure all QC documentation aligns with FDA, ICH, USP, EP, cGMP, and other regulatory guidelines. + Assist in preparing documentation for regulatory submissions and audits. + Maintain accurate version control and document tracking within electronic document management systems. + Collaborate closely with QC analysts, Outside Contract Testing Laboratories, customers, equipment manufacturers, and Quality Assurance to gather technical information. + Assist in reviewing and updating documents based on feedback from Quality Assurance and Customers. + Provide guidance to QC personnel on documentation best practices and compliance requirements. + Develop training materials for QC team members on updated SOPs, specifications, and test methods. + Support quality improvement initiatives by identifying gaps in documentation and recommending improvements. + Stay up-to-date with industry best practices, regulatory changes, and advancements in pharmaceutical quality control. Essential Skills + 4-5 years of bench experience as a chemist with expertise in HPLC, Dissolution, KF Wet Chem Sample preparation. + Strong understanding of analytical techniques and laboratory procedures such as HPLC, GC, UV-Vis, FT-IR, Malvern PSD, Water by KF, and Dissolution. + Familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP. + Excellent writing, editing, and organizational skills. + Highly skilled in Microsoft Office Suite, including Word, Excel, and PowerPoint. + Strong attention to detail and ability to translate complex scientific information into clear documentation. + Ability to work independently and collaborate effectively with cross-functional teams. Additional Skills & Qualifications + Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, or a related field. + 2-5 years of experience in technical writing within the pharmaceutical or biotech industry, preferably in Quality Control/Analytical Development. + Experience with Empower Software and solid oral dosage forms. + Ability to identify non-conformances and conduct laboratory investigations. Work Environment You will work in a laboratory setting with approximately 10 colleagues. The environment is supportive of growth and continuous improvement, with opportunities to engage in high-pay projects within a new facility. The role encourages collaboration and communication among team members to ensure compliance and quality. Pay and Benefits The pay range for this position is $40.00 - $42.00/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 East Windsor,NJ. Application Deadline This position is anticipated to close on Jul 24, 2025. 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.