Analyst, Quality Control, Development

Full Time
  • Full Time
  • Brampton

What is in it for you:

Full Benefits
Competitive Salary
Three weeks Vacation + Personal Days
RRSP Matching
Professional growth and Advancement

Our client is presently looking for an Analyst, Quality Control, Development to join their QC department.

**** must have method validation on impurities experience ****
****must have method development****
The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).

Principal Responsibilities :

  • Develop and validate methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods.
  • Develop and validate cleaning validation methods as required.
  • IV Drug release testing for product comparison.
  • Perform process validation and cleaning validation testing.
  • Perform method transfer activities.
  • Support new product introduction.
  • Product, method and raw material trouble shooting.
  • Collaborate with other departments to proactively build quality into the processes and systems.
  • Create and revise QC procedures as required.
  • Provide support for internal and Regulatory Inspections.
  • Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
  • Complete all GMP Documentation correctly and in a timely manner.
  • Participate in and/or lead Non Conformance Investigations.
  • Complete Corrective and Preventive Actions (CAPA’s).
  • Initiate, and follow through with actions required to close Change Controls.
  • Participate in Internal, Customer and Regulatory Audits.

Knowledge and Skills 

  • Bachelor’s Degree in Chemistry, or related discipline
  • 3-5 years experience in the pharmaceutical industry in a Quality Control Laboratory.
  • must have method validation on impurities experience
  • Knowledge of Pharmaceutical Manufacturing and Packaging an asset
  • Demonstrated technical writing skills
  • Well developed interpersonal and teamwork skills
  • Expert knowledge and understanding of analytical chemistry and instrumentation
  • Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC)
  • Knowledge of applicable software including LIMS, Empower and MS Office
  • Sound knowledge and application of Health Canada and FDA regulations
  • Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
  • Excellent written communication and report writing skills
  • Strong organizational skills and ability to multi-task; detail oriented
  • Excellent problem solving and judgment
  • Advanced ability in investigative techniques to troubleshoot analytical problems
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