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New Beta Innovation Canada Limited

Specialist, Quality Assurance (Manufacturing)

Details
Full Time
3 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI-CA) 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 Manager, Quality Assurance (Manufacturing) the incumbent will be responsible for providing QA oversight on a variety of GMP activities including bulk manufacturing and aseptic filling.

Key Responsibilities

  • Participate in internal and external audit activities
  • Review QMS documents such as but not limited to SOPs, deviations, discrepancies, change controls, CAPAs, excursions and investigations
  • Continuously improve QMS SOPs such as but not limited Change Control Program, CAPA Program, Deviation Program, Data Integrity, Media Fill Program, PV Program, etc.
  • Provide QA oversight in routine execution of media fill, process validation and cleaning validation activities.
  • Perform routine line clearance checks and QA oversight on shop floor.
  • Support review of Media Fill, process validation and cleaning validation documentation including batch package review.
  • Organize and coordinate trainings by creating training materials and working on the electronic training management system
  • Perform supplier and contractor qualification activities.
  • Collaborate and work closely with all departments to maintain quality culture
  • Perform other tasks as assigned

Knowledge, Skills and Experience

  • Bachelor’s Degree in Lifesciences or relevant field
  • Minimum 5 years of work experience in pharmaceutical or biologics manufacturing industry or an equivalent combination of education and experience
  • Strong quality mindset and holistic approach to guarantee product quality and patient safety under company QMS
  • Good understanding of regulatory requirements e.g EU GMP, USFDA, Health Canada etc.
  • In-depth understanding of bulk manufacturing, aseptic filling process and biologic product characteristics and familiarity with in-process-control strategy and final product testing methods
  • Experience dealing with inspectors and auditors from various regulatory authorities
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Excellent interpersonal, oral and written communication skills
  • Strong organizational skills and attention to detail

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.

Category
Quality Assurance