Job Title: Analytical Data Reviewer

Job 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.