The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that develops quality standards for medicines, dietary supplements, and food ingredients. With a strong focus on Equity = Excellence, USP collaborates with global experts to ensure the supply of safe and quality healthcare products worldwide. The organization is driven by its 1,100 professionals spread across five global locations, working towards the mission to build a healthier world.
USP believes in fostering a workplace culture that promotes Diversity, Equity, Inclusion, and Belonging (DEIB). Employees are offered meaningful mentorship and professional growth opportunities through leadership programs.
Position Overview: Reference Standard Laboratory Analyst
This is a non-supervisory role within the Reference Standard Laboratory responsible for conducting pharmaceutical analysis, troubleshooting scientific challenges, and maintaining a Good Laboratory Practice (GLP) environment.
Key Responsibilities
- Perform all testing and data analysis with precision, minimizing errors.
- Provide testing support to various USP departments like Verification, GPH, PQM, and stability teams.
- Manage sample tracking, sample archival, and chemical inventory within the laboratory.
- Coordinate with supervisors to ensure projects are completed within timelines.
- Conduct calibration of laboratory equipment as per schedule and handle IQ/OQ/PQ of new instruments.
- Ensure availability of required chemicals, columns, and instruments for projects; manage purchase requisitions accordingly.
- Maintain laboratory safety and compliance with GLP practices.
- Actively participate in internal and external audits and certification activities.
- Take on additional responsibilities assigned by supervisors as needed.
Qualifications and Skills Required
- Master’s degree in Chemistry or Pharmacy.
- 1 to 3 years of experience in a relevant laboratory environment, preferably in a pharmaceutical QC lab or contract analytical testing lab.
- Strong analytical chemistry knowledge with expertise in:
- HPLC, GC operations and wet analytical techniques (e.g., water determination, loss on drying, titrations).
- Spectroscopic analysis (UV, IR) and Empower software proficiency.
- Experience with LCMS, GCMS, thermal, or elemental analysis is an advantage.
- Knowledge of USP compendia, ICH guidelines, and FDA regulations preferred.
- Skills in ELN (Electronic Lab Notebook), ERP, or QR coding systems are a plus.
- Ability to deliver high-quality projects on time and maintain strong relationships with stakeholders.
- Excellent written and verbal communication skills.
- Adaptability to changing priorities and ability to embrace innovation.
