QC Analyst II - (Weekends)

Bimeda•Cambridge, ON

2d•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
THOROUGHNESS /DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
CHANGE AGILITY/ADAPTABILITY – The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.
FOSTERING COLLABORATION / TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team, as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respect other.

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.
Other duties as assigned.