This non-supervisory role involves conducting necessary analytical tests on Verification samples (Dietary supplements/Dietary Ingredients) using suitable methods. The Scientist will enhance the laboratory’s scientific proficiency and work ethic by offering extensive technical support and knowledge, providing valuable observations and insights into challenging projects, and supporting the Verification Program through analytical tests and comprehensive summary reports.
Key Responsibilities:
- Conduct Verification projects by performing individual analytical tests assigned by the Team Leader.
- Complete projects within designated timelines and priorities.
- Demonstrate a robust scientific approach to laboratory analysis.
- Utilize personal experience, academic training, and technical insights to address complex technical issues.
- Compile project reports and respond to QA observations.
- Execute all testing and data analysis with precision, minimizing errors.
- Show commitment to continuous learning and personal development.
- Propose and implement new approaches or processes to enhance laboratory operations.
- Influence project direction positively by aligning own work with the overall direction of laboratory projects.
- Assist with additional testing programs and laboratory maintenance tasks.
- Ensure compliance with Good Laboratory Practices (GLP) and safety systems.
- Maintain equipment calibration according to the schedule.
- Coordinate the procurement of chemicals, columns, glassware, etc., considering project deadlines.
- Adhere to USP mission, policies, and procedures.
- Cultivate positive relationships with QA, HR, Purchase, Accounting, IT, and other departments.
- Participate in preparation and planning for ISO-9001 & ISO-17025 certification/recertification, including internal QA and external audits.
- Support Global Public Health (GPH), Reference Standard Laboratory (RSL), and other departmental teams as required for analytical testing, review, execution, and approval.
Qualifications and Requirements:
- Master’s degree in pharmacy or Analytical chemistry.
- 1 to 3 years of relevant laboratory experience.
- Experience in a high-volume pharmaceutical manufacturing QC laboratory or a contract pharmaceutical analytical testing laboratory.
- Proficiency in HPLC/GC operation with Empower software, ICP-OES, ICP-MS, LC-MS, and dissolution analysis.
- Adept in operating and troubleshooting related analytical instrumentation (IR, KF, UV).
- Exceptional communication and presentation skills, verbal and written.
- Familiarity with ICH guidelines and FDA regulations.
- Proficiency in Electronic Laboratory Notebook (ELN) is preferred.
- Strong commitment to high-quality work and problem-solving skills.
