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Analytical Method Development and Validation Chemist
PLZ Corp
ON · Mississauga, ON
- Full-time
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PLZ Corp
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PLZ Corp

Analytical Method Development and Validation Chemist

ON, Canada
Mississauga, ON, L5T 2V4, Canada

Full-time

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Job details

Job type: Full-time
Posting language: English
Posted: Nov 13, 2026

Original job description

KEY RESPONSIBILITIES

Develop and optimize analytical methods for pharmaceutical, OTC drug, consumer healthcare, personal care, or related products.
Plan, author, execute, and complete analytical method development, validation, verification, and transfer protocols and reports.
Evaluate accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness, and system suitability, as applicable.
Design scientifically justified experiments to improve method performance, sensitivity, reproducibility, efficiency, and ease of routine use.
Perform technical and statistical evaluation of calculations, chromatograms, spectra, audit trails, electronic records, and supporting documentation.
Coordinate method transfers between internal laboratories and qualified external laboratories, including comparative testing and discrepancy resolution.
Operate, maintain, and troubleshoot HPLC/UHPLC, GC, UV-Vis, FTIR, potentiometer and other applicable analytical equipment.
Prepare and maintain analytical methods, specifications, SOPs, work instructions, validation plans, risk assessments, protocols, reports, and controlled forms.
Investigate OOS, OOT, atypical, and invalid results and document scientifically justified root causes, conclusions, and corrective or preventive actions.
Support deviations, change controls, CAPA, laboratory investigations, effectiveness checks, and continuous improvement initiatives.
Provide technical support for instrument qualification, calibration, preventive maintenance, repair, software upgrades, and vendor activities.
Train and qualify laboratory personnel on new or revised methods, instruments, software, and procedures.

AGILENT OPENLAB CDS PLUS - REQUIRED KNOWLEDGE OR EXPERIENCE

Hands-on experience using Agilent OpenLab CDS Plus for sequence setup, data acquisition, processing methods, calculations, reporting, and controlled electronic records.
Ability to review chromatographic data, metadata, audit trails, processing changes, system suitability, and electronic records for completeness and data integrity.
Experience troubleshooting instrument-to-software communication, acquisition failures, processing issues, and report-generation concerns.
Working knowledge of role-based access, electronic signatures, audit trails, backup and recovery, and computerized-system lifecycle controls in a regulated laboratory.
Experience supporting OpenLab implementation, configuration, validation, upgrade, migration, or periodic review is strongly preferred.

QUALITY, COMPLIANCE & DATA INTEGRITY

Follow current GMP, Good Documentation Practices, laboratory safety requirements, and ALCOA+ data integrity principles.
Apply relevant analytical procedure development and validation concepts, including ICH guidelines , applicable USP requirements, and internal procedures.
Support compliance with electronic records and electronic signature requirements, including 21 CFR Part 11 principles and applicable computerized-system controls.
Support internal audits, customer audits, regulatory inspections, product transfers, and laboratory remediation activities.
Maintain complete, accurate, contemporaneous, attributable, legible, original, and traceable laboratory and validation records.

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More about this job

Responsibilities

Develop, optimize, and validate analytical methods for pharmaceutical and consumer healthcare products while ensuring compliance with GMP and data integrity standards. Coordinate method transfers between laboratories and provide technical support for instrument maintenance, troubleshooting, and staff training.

Requirements

Requires hands-on experience with Agilent OpenLab CDS Plus and a strong working knowledge of analytical instrumentation such as HPLC, GC, and FTIR. Candidates must be proficient in ICH guidelines, USP requirements, and 21 CFR Part 11 compliance within a regulated laboratory environment.

Skills

Analytical method development
Method validation
HPLC
UHPLC
GC
UV-Vis
FTIR
Agilent OpenLab CDS Plus
GMP
Data integrity
ICH guidelines
USP requirements
21 CFR Part 11
Laboratory investigations
Technical writing
Statistical evaluation

Visa sponsorship

Not detected in the job text

Keywords

Analytical Method Development
Validation
Pharmaceutical
OTC Drug
HPLC
UHPLC
GC
UV-Vis
FTIR
Agilent OpenLab CDS Plus
GMP
Data Integrity
ICH Guidelines
USP
21 CFR Part 11
SOP
OOS
CAPA
Instrument Qualification
Calibration
Chromatography
Spectra
Audit Trails
Electronic Records
Method Transfer
Root Cause Analysis
Regulatory Compliance
Laboratory Safety
ALCOA+
Technical Support

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Open jobs in Canada

Analytical Method Development and Validation Chemist

Packer/Packager, Hand