Analytical Chemist

Position

Analytical Chemist

Company and Location

Stratum Analytical, 44 Richmond St. W Suite 101

Employment Type

Permanent, full time

Hours Worked

37.5 hours / week

Direct Reports

No

Position Summary

The Analytical Chemist is responsible for performing, developing, and validating analytical methods to test pharmaceutical products in compliance with applicable regulatory standards, including USP, ICH, and GMP requirements. This position is also responsible for overseeing the equipment maintenance program ensuring equipment is qualified prior to the re-qualification deadlines. The Analytical Chemist works collaboratively within the laboratory to generate accurate, reliable data while maintaining strict adherence to data integrity, safety, and quality systems. The role also involves close collaboration with Quality Assurance to investigate out-of-specification (OOS) and out-of-trend (OOT) results and to support deviations and corrective and preventive actions (CAPAs).

General Responsibilities & Essential Functions

Analytical Testing

• Perform routine and non-routine analytical testing of pharmaceutical drug substances and drug products using techniques such as titrations, stability-indicating HPLC analysis, pH analysis, viscosity assessment, and visual inspection.
• Perform testing on samples promptly, ensuring adherence to assigned testing deadlines.
• Communicate with the manager regarding any challenges in meeting scheduled testing timelines.
• Promptly notify management of unexpected test outcomes.
• Document results in a standardized format and record them accurately and on time.
• Contribute to the integration of new testing techniques into the lab.
• Potentially develop new laboratory methods in response to client or market needs.
• Stay current with industry technology and instruments, with a focus on HPLC analytical chemistry applications in pharmaceuticals.
• Support all laboratory workstations as needed, providing backup support as required.
• Design customized stability studies to meet customer needs.
• Assist in R&D and stability testing, including preparing samples, writing protocols, establishing specifications, performing testing, entering data, and writing reports.
• Use statistical methods to interpret results using Excel or other statistical software.

Equipment Maintenance Oversight

Quality Processes

Compliance Management

Qualifications

Education

Specific Working Conditions or Physical Requirements

#J-18808-Ljbffr