Job Title: Analytical Data Reviewer

Job Description

As an Analytical Data Reviewer, you will be responsible for developing and maintaining essential documentation related to Quality Control and Analytical Development. Your role will ensure compliance with regulatory guidelines, support collaborative efforts, and contribute to continuous improvement initiatives within the laboratory.

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/Certificate of Analysis, validation protocols (IQ/OQ/PQ), and stability study reports.
• Prepare method validation protocol/reports, method transfer protocol/reports, technical documents, including change controls, deviations, CAPAs, and OOS (Out of Specification) and laboratory 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 (internal and external).
• Maintain accurate version control and document tracking within electronic document management systems (ACE).
• Work 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.
• Proficiency in HPLC Dissolution, KF Wet Chemistry, Sample preparation.
• Experience with Solid Oral Dosage and Empower Software.
• Ability to identify non-conformance in laboratory settings.
• Strong understanding of analytical techniques (HPLC, GC, UV-Vis, FT-IR, Malvern PSD, Water by KF and Dissolution, etc.) and laboratory procedures.
• Familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP.

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.
• Excellent writing, editing, and organizational skills.
• Proficiency 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.

Work Environment

The role is based in a laboratory setting with a team of 10 people. The facility is new, offering a dynamic and growing environment. High pay and opportunities within a growing Contract Manufacturing Organization (CMO) make this role attractive.