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New B Innovation Ltd. Logo

Specialist, Quality Assurance

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Burnaby, BC
Job Type icon
Full Time
Job Category icon
Biotechnology

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POSITION

Specialist, Quality Assurance

ABOUT THE COMPANY

New β Innovation Ltd. (NBI) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.

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 QA Manager, the incumbent will focus on Computerised System Validation (CSV) to ensure the IT infrastructure and electronic system used at New B Innovation meets GxP standards to support GMP manufacturing and testing activities in bio-pharmaceutical industry.

KEY RESPONSIBILITIES

  • Create, review and maintain CSV and IT infrastructure and SOPs and policies
  • Initiate and/or review CSV documents for Production process equipment, QC analytical instruments, SAP/ERP/Documentation system, spread sheet and IT infrastructure qualification
  • Lead the implementation of the company’s eQMS system and maintain the system from the CSV perspective
  • Participate in and guide the team in generating, modification design, configuration specifications and network diagrams
  • Ensure qualification processes are executed as defined by procedures
  • Support process of infrastructure change management and qualification procedures
  • Conduct internal audits to computerized system and IT infrastructure, follow up on the CAPAs.
  • Communicate status, solutions and concerns within the team. Facilitate and address issues within project
  • Collaborate with vendor(s), Quality department, and technical individuals throughout project 

KNOWLEDGE, SKILLS AND ABILITIES

  • Familiar with Part 11, Annex 11, GAMP requirements
  • Experience with the Quality Management System
  • 2 - 5 years’ experience in CSV is required, experiences in pharmaceutical industry is preferred
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Strong organizational skills and attention to detail
  • High proficiency in MS Word/Excel and good writing skills

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!

HOW TO APPLY

Please apply through our online application system, found at: 

https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=d2be7702-ad25-4a0b-8f2e-a98f72b7158b&jobId=83714&lang=en_CA&source=CC3&ccId=19000101_000001


Posted: June 22, 2018
Closes: July 10, 2018
Email Address:
Company Info
Size:
51-200 employees
Industry:
Technology

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About New B Innovation Ltd.

Established in 2007, head quartered in Hong Kong, New B Innovation Canada (NBI) is committed to providing innovative products to fulfill medical needs following Good Manufacturing Practices (GMP) i...