Role Summary: As a Quality Assurance Specialist, your primary responsibility is to uphold the compliance of our analytical laboratory operations with regulatory standards and internal quality management systems. You will meticulously review analytical raw data, documentation, and reports to ensure adherence to cGMP regulations and FDA guidelines. Additionally, you will play a key role in conducting investigations into out-of-specification (OOS) results, contributing to internal audits, and facilitating the implementation of quality management solutions.

Roles & Responsibilities:

• Conduct thorough reviews of analytical raw data to verify compliance with specifications, SOPs, cGMP regulations, and FDA guidelines.
• Issue Certificates of Analysis following comprehensive assessments of analytical raw data.
• Critically assess and approve data packages and technical reports to guarantee alignment with SOPs and FDA cGMP standards.
• Review reports pertaining to Method Validation, Method Verification, and raw data of API, raw materials, and finished products.
• Ensure that SOPs and method documentation are kept current and comply with FDA cGMP/GLP requirements.
• Collaborate with the Laboratory Team and Client Relations to investigate, troubleshoot, and resolve out-of-specification (OOS) results.
• Scrutinize equipment/instrument logbooks to confirm accuracy and completeness.
• Verify the completeness and adequacy of all documentation (both hard copy and digital) to withstand FDA audits.
• Support the QA manager in conducting Internal Audits and preparing for external audits.
• Identify training needs for chemists related to documentation compliance.
• Ensure adherence to Company policies and Quality Management System (QMS) requirements, assisting in the implementation of new QMS solutions.