Job Details

Senior Specialist, Quality Assurance

Title
Senior Specialist, Quality Assurance
Length
Full Time
Salary
not disclosed
Employer

New B Innovation Canada

Location
Burnaby
British Columbia
Date Posted
10/09/2018 - 11:15
Closing Date
31/01/2019 - 11:15
Job Description
Summary: 

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 be responsible for providing QA oversight on a variety of ongoing GMP activities including bulk manufacturing and aseptic filling.

Education & Qualifications: 
  • Degree in Life Sciences or relevant major
  • 3 - 5+ years of experience in pharmaceutical or biopharmaceutical industry.
  • Strong quality mindset and holistic approach to guarantee product quality and patient safety under company QMS.
  • In-depth understanding of bulk manufacturing, aseptic filling process and biologic product characteristics. Familiarity with in-process-control strategy and final product testing methods.
  • Ability to directly and confidently engage in the conversation with inspectors from major regulatory authorities
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Working efficiently with the ability to be innovative and identify creative solutions
  • High proficiency in MS Word/Excel and good writing skills
  • Strong sense of pride in ownership of, and quality of work
  • Attention to detail
Duties & Responsibilities: 
  • Author and continuously improve QMS SOPs, i.e. Batch Dispositions, OOS/OOT, Tech transfers, Process Validations, Deviations, Change Controls, CAPA, QRM, and Data Integrity.
  • Perform Quality Assurance oversight on bulk manufacturing, aseptic filling activities and other supporting functions in accordance with internal company standards and external regulation/guidance. Core areas of oversight will include production floor, calibration, maintenance, validation, qualification, sampling and testing.
  • Review and approve GMP documentations; including but not limited to SOP’s, Batch Records, Risk Assessments, validation/ qualification documents, sample/ test records, Deviations, Change Controls, CAPA and alarm reports.
  • Work closely with Production and QC on CMC tech transfer and scale up activities for the OC product.
  • Review Process Validation activities and generate Master Batch Record templates.
  • Continuously improve manufacturing process risk assessments for bulk and aseptic filling activities and facility risk assessments. Maintain traceability matrix to ensure completion of the proposed actions to address specific identified risks.
  • Review and approve material assessments, material qualification documentation and specifications of Production raw material, excipient and disposables.
  • Conduct periodic reviews of the process and QC equipment, support re-validation activities according to outcome of the review.
  • Participate in internal and external audits when necessary, and contribute to drafting the audit plan and report.
Other Information: 

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: http://www.newbinnovation.ca/join.aspx