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Job Title:
QC ANALYST (Level – 2)
Date Posted:
04/09/26
Ref. Number:
822
Type:
Full Time
Part Time
Location:
Richmond Hill
Requirements:
POSITION REQUIREMENTS : (Work Status, Qualification, Knowledge, and Experience)
Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
Must be living in Canada, preferably in Toronto area
Minimum M.Sc. or B.Sc. degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines with at least of 4 years direct hands-on experience working in pharmaceutical disciplines.
Solid knowledge and expertise (including operation, Qualification, trouble-shooting, and maintenance) working with laboratory instrumentation such as Dissolution, HPLC, GC, ICP-MS, UV-VIS, FT-IR, TOC, TLC, KF, etc.
Familiarity to LC/MS/MS instrumentation and Nitrosamine impurity analysis would be an advantage
Possess extensive experience and in-depth technical knowledge in the method validation, and application of analytical methods used to support pharmaceutical product development and quality control. This includes a strong focus on assay determination, related substances (impurities) analysis, and residual solvents (organic volatile impurities) testing, aligned with ICH, USP, EP, and regulatory expectations.
Well versed in understanding USP, BP, EP, and JP, methods and specifications.
In-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
Strong attention to detail
Strong problem solving and analytical skills including decision analysis and implementation
Computer Proficiency with MS office (Excel, Word, PowerPoint), Spreadsheets, etc.
Strong ability to function as a team member; ability to communicate effectively with team members and other plant personnel, both verbally and in writing
Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.
Be punctual, team player, fast learner, and have strong Interpersonal and communication skills
Description:
REPORTS TO: Director of Laboratory Operation
POSITION SUMMARY:
The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for analyzing laboratory raw material, in-process, and finished products samples using various chemical and instrumental techniques, in accordance with compendial; USP, BP, EP, and JP methods and specifications and established in-house testing methods, while under minimum supervision.
The Quality Control Analyst is responsible to operating, maintaining, performing and basic troubleshooting of analytical instruments, including; Dissolution, HPLC, UPLC, LC/MS, GC, GC/MS, ICP-MS, etc.
ESSENTIAL FUNCTIONS
Perform raw material, in-process, finished product, and stability sample testing using instrumental analytical, wet chemicals, and physical analytical methods and techniques following the written procedure or compendial methods.
Prepare analytical equipment for experiments; Including reagents, standards, test solutions, and mobile phase as required by the test procedure.
Perform analytical method Transfer, Verification, Validation and Stability testing.
Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
Ordering general lab supplies (chemicals/non-chemicals) when required.
Document analytical test results in lab notebooks; Ensure the data generated is accurate and meets the specifications, report results on the testing worksheets (finished products and raw materials) according to standard operating procedures in a timely manner, meeting specified deadlines.
Maintain laboratory lab-books, equipment logbooks, and trackers on daily basis in accordance with department policies and procedures.
Demonstrate sound knowledge of Pharmaceutical Compendial (i.e., USP, BP, EP, JP, etc.) General Chapters’ methods
Effectively manage the prioritization to meet multiple goals and timelines.
Demonstrate a strong understanding of cGMP, cGLP, Health Canada, FDA, ICH, and other regulatory guidelines
Be able train new or existing personnel as identified by QC management.
Notify any aberrant/OOS/OOT results to QC management and participate to investigate results following the SOP.
Conduct laboratory instruments qualification, calibration, and preventive maintenance when requested
Be able to work in a collaborative, fast-paced environment.
Hours per week:
40
Rate of Pay:
$50,000K - $60,000K