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Specialist, Quality Assurance (Manufacturing)

Location
Burnaby, BC Canada
Details
Full Time
11 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (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 Assistant Manager/ 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

  • Perform routine line clearance checks and QA oversight on bulk manufacturing, aseptic filling activities, aseptic gowning training and qualification and other supporting functions.
  • Ensure regular GMP compliance on the production floor. 
  • Prepare and review process validation and cleaning validation documents
  • Provide QA oversight in routine process validation and cleaning validation activities
  • Participate in internal and external audit activities 
  • Create and revise QMS SOPs as assigned.
  • Review GMP documentation including but not limited to SOPs, batch records, qualification protocols, studies, reports, etc.
  • Review deviations, discrepancies, change controls, CAPAs, investigations from technical perspective
  • Support in improving and coordinating company’s GMP training program, maintaining training database, drafting training schedule, organizing trainings and managing training records as required
  • Collaborate and work closely with all departments to maintain quality culture
  • Perform other tasks as assigned

KNOWLEDGE, SKILLS AND ABILITIES

  • Bachelor’s Degree in Pharmaceutical or Biopharmaceutical field
  • Minimum 2 years’ work experience in pharmaceutical or biologics manufacturing industry or an equivalent combination of education and experience
  • Good understanding of regulatory requirements e.g EU GMP, USFDA, Health Canada etc.
  • Excellent interpersonal, oral and written communication skills
  • Ability to think creatively and innovatively
  • Ability to work independently and in a team environment
  • High proficiency in MS Word/Excel
  • 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.

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

Category
Biotechnology

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About New Beta Innovation Canada Limited

New B Innovation (NBI) is a dedicated player in the global biotechnology market with a vision to advance life sciences and health care using the latest technologies and innovative approaches to del...

Read More
Industry
Technology
Size
51-200 employees