Roles & Responsibilities:

1. Analyze raw analytical data to ensure it meets specifications and complies with Standard Operating Procedures (SOPs), cGMP regulations, and FDA guidelines.
2. Validate and issue Certificate of Analysis (CoA) after thorough review of analytical data.
3. Conduct critical review of data packages and technical reports generated by the Laboratory Team to ensure adherence to SOPs and FDA cGMP standards.
4. Evaluate reports related to Method Validation, Method Verification, and raw data of API, raw materials, and finished products.
5. Maintain and update Standard Operating Procedures (SOPs) and method documentation to ensure compliance with FDA cGMP/GLP requirements.
6. Collaborate with the Laboratory Team and Client Relations to investigate, troubleshoot, and resolve out-of-specification (OOS) results.
7. Monitor equipment/instrument logbooks for accuracy and completeness.
8. Ensure completeness and compliance of all documentation (both hard copy and digital) to withstand FDA audits.
9. Support QA manager in Internal Audits and preparation for external audits.
10. Identify training needs for chemists regarding documentation to ensure regulatory compliance.
11. Uphold compliance with Company policies and Quality Management System (QMS) requirements.
12. Assist QA Team in implementing/upgrading new QMS, documentation, and change control solutions.
13. Manage day-to-day activities independently to align with Laboratory and Quality objectives.

Requirements:

1. Hold a Bachelor's degree in Chemistry coupled with a minimum of 3 years of hands-on experience within an FDA-regulated analytical laboratory.
2. Possess a comprehensive grasp of cGMP/GLP requirements and Quality Assurance (QA) protocols tailored to analytical laboratory settings.
3. Proficient in meticulously evaluating raw data, laboratory data packages, reports, and Standard Operating Procedures (SOPs).
4. Demonstrated ability in conducting thorough investigations of Out-of-Specification (OOS) instances to pinpoint root causes effectively.
5. Track record of adeptly managing Change Control processes and proficiently drafting Deviation reports.
6. Strong command of various analytical chemistry methods, including but not limited to LC, GC, IR, UV, dissolution, viscosity, and melting point analyses.
7. Extensive experience in the analysis and GMP reporting procedures associated with Over-the-Counter (OTC) drugs, cosmetics, dietary supplements, and/or botanical products.
8. Exceptional technical writing skills coupled with the ability to articulate complex concepts clearly.
9. Demonstrated capability to work independently while fostering a collaborative team environment.
10. Organized and adept at planning workloads efficiently and effectively.
11. Proven track record of consistently delivering results to clients within specified timelines.