Analytical Chemist

#LI-DNI JOB DESCRIPTION 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 Support and manage the laboratory equipment maintenance program to ensure instruments remain in a qualified and operational state.

Coordinate routine calibration, preventive maintenance, and qualification activities in accordance with GMP requirements and internal procedures.

Maintain accurate equipment logs, calibration records, and service documentation.

Identify equipment issues, initiate maintenance requests, and support troubleshooting and repairs.

Ensure instruments are appropriately labeled for status (e.g., in service, out of service, calibration due).

Quality Processes Lead and collaborate with the Quality Assurance department to address quality incidents such as OOS results and deviations by participating in initial investigations.

Evaluate quality processes against industry standards and regulatory requirements.

Assist the Quality Assurance team in identifying impacts, root causes, and CAPAs to ensure regulatory compliance.

Aid in developing Corrective and Preventive Action (CAPA) plans, ensuring timely implementation.

Participate in the creation of Change Control documentation.

Write, revise, and review methods, work instructions, reports, and SOPs as required.

Compliance Management Adhere to company policies and all applicable SOPs.

Perform all work in compliance with ISO 17025, Controlled Substance regulations, ISO 9001, cGMP, cGLP, A2LA, WHMIS, USP, ICH, and regulatory requirements.

Adhere to data integrity principles (ALCOA+) and laboratory best practices.

Follow all safety, environmental, and waste disposal procedures.

Support internal audits, client audits, and regulatory inspections as needed.

Maintain a clean, orderly, and safe laboratory workspace and adhere to all health and safety protocols.

Qualifications Strong knowledge of pharmaceutical analytical chemistry and quality control principles.

Strong…