Researcher / analyst
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
USP promotes Diversity & Inclusion at Workplace and encourages Equal Employment Opportunity and Affirmative Action
Summary of the Position
- This is a Non Supervisory position in Verification and GPH, responsible for Analytical activities for VER and GPH samples and maintaining a GLP environment in the lab. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in verification and GPH testing, efficient and effective laboratory operations.
Roles and Responsibilities
Completes the projects as per the project timelines and priorities.
Demonstrates solid scientific approach to analysis in the laboratory.
Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory;
Compiles project reports and responds QA observations.
Executes all testing and analysis of data with excellence and essentially no errors;
Demonstrates a strong desire to continue learning and grow personal capability;
Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;
Assists with other testing programs and housekeeping duties in the laboratory as needed.
Prepares and reviews SOPs.
Ensures the calibration of the equipment as per the schedule.
Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
Ensures and follows USP mission, policies and procedures.
Maintains good relationship with QA, HR, Purchase, accounting, IT and other dept.
Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
Supports collaborative testing, GPH, RSL and other departmental teams in terms of project testing, review, execution and approval whenever needed.
Master degree in pharmacy or chemistry.,Minimum 5 to 7 years of relevant laboratory experience.
Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory.
- Ability to lead projects to completion with a high degree of scientific expertise. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods (USP, BP, EP, etc.). Expert in ICP-OES, HPLC, GC,ICP-MS,LC-MS, Dissolution analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, etc), strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred. Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred. Proficiency with electronic documentation systems strongly preferred. Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. Skills to anticipate, troubleshoot, and solve technical problems.