QC Analyst II - (Weekends)

Bimeda•Cambridge, ON

4d•CA$55,000 - CA$65,000•Onsite

About The Position

Reporting to the Quality Control Project Lead, the QC Analyst II is responsible for the analysis of raw materials, in-process, finished products and stability samples using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and Bimeda quality standards. This position also provides testing support for the Stability Program. Quality Control Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts.

Requirements

3-5 years in a Pharmaceutical Analytical testing lab & supporting stability programs
B.Sc. in Chemistry, Biochemistry or related discipline
Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays

Responsibilities

Conducts all analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water and stability program samples. i.e. pH, conductivity, TOC, viscosity, potency and impurity tests.
Reviews data, results and documentation for QC analytical testing.
Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
Prepares samples for analysis according to company methods, SOPs & applicable compendia (USP/EP).
Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF and other instruments.
Documents analytical test results as they occur in logbooks and in-process test data in Production dockets as required.
Analyzes data; keeping the supervisor informed of discrepancies, deviations, out of specifications (OOS) data and unusual trends as they occur.
Assists with quality investigations as required.
Ensures that reagents and supplies are replenished by informing QC Supervisor or preparing PO requisitions when required.
Performs calibration of equipment, troubleshooting issues and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
Supports and provides training and guidance to junior analysts.
Ensures that work areas are kept clean and tidy and cleans glassware after use when required.
Provides independent oversight on the production floor, verifying that manufacturing activities are performed in accordance with approved procedures, specifications, and regulatory expectations. This includes but is not limited to, Line clearance activities, In process and final QA checks AQL checks and Provide support and guidance for failure events.
Other duties as assigned.