Analyst, Quality Control - Burnaby, Canada - New Beta innovation canada Ltd.

Sophia Lee

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Sophia Lee

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Description

ABOUT THE COMPANY


Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.


POSITION OVERVIEW


Reporting to the Assistant Manager/Manager Quality Control, the incumbent will perform a variety of analytical chemistry related functions and will be part of a team responsible for ensuring the integrity of the analytical chemistry laboratory in support of sterile drug product manufacturing.


The incumbent will need to be flexible with their work hours and schedule, and may be required to perform shiftwork to fulfil manufacturing requirements.

Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.


Key Responsibilities

  • Perform sampling and routine testing in accordance with approved testing methods for raw materials, inprocess materials, packaging materials and finished products
  • Perform routine water testing (e.g. TOC) in support of environmental monitoring program for cleanroom facility and utilities
  • Follow Standard Operating Procedures (SOP) and conduct test methods for testing in the analytical laboratory (HPLC, osmometer, UV-Vis, etc.)
  • Perform stability testing to support shelf life studies for the finished product'
  • Comply with Good Manufacturing Practice (GMP) and maintain strict and accurate quality control documentation of all test procedures and results
  • Assist in method validation of analytical test methods
  • Assist in instrument qualification and computerized system validation (CSV)
  • Perform equipment calibration as required for GMP compliance
  • Ensure that lab cleanliness and safety standards are maintained
  • Arrange and monitor shipment of raw materials and products for external testing
  • Develop/write and maintain high quality Standard Operating Procedures (SOP)
  • Perform other related tasks as needed

Knowledge, Skills and Experience

  • Degree in Life Sciences. Degree in Chemistry preferred
  • Minimum 3 years relevant work experience in the pharmaceutical or biological manufacturing industry with good knowledge of method validation requirements. Experience using HPLC, TOC, and UV-Vis instrumentation and software
  • Experience with Analytical test method validation is an asset
  • Experience with instrument qualification, computerized system validation would be an asset
  • Have working knowledge of Good Manufacturing Practice (GMP) and good documentation practices
  • Excellent interpersonal and communication skills, ability to work independently and in a team environment
  • Efficient, with the ability to be innovative and provide creative solutions
  • Ability to complete work in a timely manner with a strong attention to detail and sense of pride

WHY JOIN NBI?
The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it's hard to beat working in life sciences.

We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees' growth with the company.

If you are interested in joining our team, we encourage you to APPLY today

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