Documentation Specialist - E&L (Extractable & Leachable) Lab

Key Role & responsibilities

• Scientific Documentation: Prepare, review, and maintain detailed reports for all E&L testing, including study protocols, raw data, method development, validation, and final reports.
• Ensure that all documentation is accurate, complete, and prepared according to company SOPs and regulatory guidelines.
• Collaborate with scientists to document study findings and analytical data, ensuring clarity and precision in all reports
• Ensure that all documentation complies with relevant regulatory requirements such as FDA, EMA, USP, ISO 10993, and ICH guidelines.
• Maintain organized and secure documentation systems (both electronic and physical) for all laboratory records, including method validation reports, instrument calibration logs, SOPs, and study protocols.
• Manage document control systems, ensuring proper versioning and archival of all E&L study documentation

Preferred candidate profile

• 3-5 years of experience in laboratory documentation within a regulated environment, preferably related to E&L studies or analytical sciences.
• Strong understanding of regulatory guidelines (FDA, EMA, ICH, USP) and Good Documentation Practices (GDP).