Chemical Technologist

Auxilium Health; Oshawa; On-site; CAD 55,000 - 75,000; Full time

Job summary

Stratum Analytical is seeking a Chemical Technologist in Oshawa, ON. The role focuses on analytical testing of pharmaceutical substances and products, instrument setup, and method validation support. Collaboration with QA and cross-training across departments is expected.

The candidate should have strong knowledge of analytical chemistry, GMP, and data integrity, with experience in HPLC and regulatory standards. The position emphasizes compliance and accurate data handling.

Qualifications

• Bachelor's degree in Chemistry or college diploma in science as a minimum.
• Two years of analytical lab experience preferred.
• Experience with GMP, ISO 17025, and data integrity practices.

Responsibilities

• Perform routine and non-routine analytical testing of drug substances and products.
• Prepare samples, set up instruments, and maintain equipment per SOPs.
• Support QA investigations, CAPAs, and regulatory compliance.
• Document results accurately and timely in validated systems.

Skills

HPLC

GMP/ICH

Data integrity

Analytical chemistry

ISO 17025

Education

Bachelor's in Chemistry

College diploma in science

Tools

HPLC systems

ICP-MS

GC/LC-MS

Job description

#LD-NI

JOB DESCRIPTION

POSITION

Chemical Technologist

COMPANY AND LOCATION

Oshawa, ON

EMPLOYMENT TYPE

Permanent, full time

HOURS WORKED

37.5 hours/week

DIRECT REPORTS

No

POSITION SUMMARY

The Chemical Technologist provides hands-on technical support to the Analytical Chemistry Department by performing routine laboratory activities, sample preparation, instrument setup and maintenance, reagent preparation, and documentation in accordance with established SOPs and quality systems. This roll will also including performing, developing and supporting validation of analytical methods to test pharmaceutical products in compliance with applicable regulatory standards, including USP, ICH, and GMP. The position also offers opportunities for cross-training and professional development, with the technician learning and providing support to other laboratory departments as needed. 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.
• Support development of 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.
• 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.

Cross Functional Support

• Support other laboratory departments such as microbiology, sterility or molecular biology as needed.
• This may include but is not limited to environmental monitoring, assisting sterility tests, daily lab upkeep, equipment management, inventory management, plate incubation and enumeration, and documentation.

Quality Processes

• Support and collaborate with the Quality Assurance department to address quality incidents such as OOS results and deviations by participating in initial investigations.
• 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 and execution 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 good documentation practices and data integrity principles (GDP, ALCOA+, data integrity for computerized systems) 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 understanding of ISO 9001 standards and quality management principles.
• Strong understanding of ISO 17025 standards for testing and calibration laboratories.
• In-depth knowledge of Health Canada and GMP regulations.
• Experience with sample preparation chemistry and wet chemistry analysis.
• Proficiency in Stability-Indicating HPLC method development and validation, including HPLC troubleshooting and maintenance.
• Competence in laboratory-related computer applications and programs.
• Excellent analytical, decision-making, and interpersonal skills.
• Strong verbal and written communication abilities.
• Problem-solving skills for routine and complex laboratory issues.
• Physical dexterity for accurate and precise testing.
• Ability to read, understand, and comply with company policies, SOPs, and safety regulations.
• Intermediate skills in Microsoft Office (Word, Excel, Outlook, and PowerPoint).

Education

• A post-secondary education in Chemistry is required; a university degree is preferred. However, a college diploma in a science-related field (minimum two-year program) is also acceptable.
• Minimum of two years' experience in an analytical laboratory or a related field (Wet Chemistry, Gas Chromatography, Liquid Chromatography, Mass Spectrometry, ICP/ICP-MS, Microbiology).
• Experience in microbiology and/or pharmaceutical industry is a plus.

Specific Working Conditions or Physical Requirements

• Ability to carry laboratory equipment, reagents, and samples.
• Fine motor skills and manual dexterity for tasks such as pipetting, handling small samples, and operating laboratory equipment.
• Comfort with wearing PPE, including lab coats, gloves, safety glasses, and respirators when necessary.
• Safe handling of chemicals and adherence to all safety protocols.
• Willingness to work with hazardous chemicals (NIOSH).
• Capability to work in a Biological Safety Cabinet and or Containment Ventilation Enclosure.
• Flexibility to modify work hours to support the facility after hours or on weekends, as needed and where appropriate notice has been given.

Stratum Analytical is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.

This position is being posted to fill an existing vacancy within our team.