Specialist, Quality Assurance

4 months ago

Burnaby, Canada New Beta innovation canada Ltd. Full time

**ABOUT THE COMPANY**

New Beta Innovation Canada Limited (NBI-CA) is a biopharmaceutical manufacturer of hemoglobin-based therapeutics. In Burnaby, BC, we have a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, with custom-designed equipment for commercial-scale production. Our production processes are undergoing validation for rigorous GMP requirements.

Our operations include a full in-house analytical laboratory, a water purification plant, a skilled engineering team, and experts in compliance and regulatory affairs. These teams work collaboratively to ensure the safety and quality of both our processes and product. With headquarters in Hong Kong, NBI has a global presence in Canada and New Zealand.

We are a committed and innovative team who are passionate about doing great work to make a positive impact on animal health. We are always on the look-out for creative and passionate people who are eager to contribute to a bigger purpose.

**POSITION OVERVIEW**

Reporting to the Assistant Manager, Quality Assurance (QMS)/ Senior Manager, Quality Assurance and Validation the incumbent will support implementation of the Quality Management Systems (QMS) and perform general quality system oversight. Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.

**1. Key Responsibilities**
- Ensure the quality system is effectively implemented and maintained; including but not limited to Deviation, Change Control, CAPA, OOS, Audit, Supplier/Outsourced Activity Qualification, equipment file and Specification
- Participate in internal, external and third-party audit activities
- Create and revise QMS procedures as assigned
- Perform timely review of documentation including but not limited to Deviations, CAPAs, Change Controls, SOPs, OOS, Specifications, protocols, reports, etc.
- Act as a quality point person for providing guidance and feedback on quality items.
- Work with relevant departments to ensure timely closure of QMS items
- Actively contribute to continuous improvement initiatives
- Oversee and manage the assigned QA project activities, e.g. the e-QMS system
- Conduct training on QA processes for employees
- Perform other tasks as assigned

**2. Knowledge, Skill and Experience**
- Bachelor’s Degree in Pharmaceutical or Biopharmaceutical field
- Minimum 3 years’ work experience in pharmaceutical or biologic manufacturing industry OR an equivalent combination of education and experience, sterile experience
- Hands on experience with QMS documents (Deviation, change control, CAPAs) and quality decision making
- Strong Knowledge of cGMP, US and EU regulatory requirements
- Participation in internal/external/third-party audit is an asset
- Excellent interpersonal, oral and written communication skills
- Work efficiently with the ability to be innovative and identify creative solutions
- Ability to work independently and in a team environment
- High proficiency in MS Word/Excel
- Strong organizational skills and attention to detail
- Strong sense of pride in ownership of, and quality of work

**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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