Job Description

Summary

We are currently seeking Senior Quality Assurance Specialists to join our growing Quality Assurance team!

In this role, you will be responsible for managing one or more systems and processes within STEMCELL?s Quality Management System (QMS), and leveraging your experience and critical thinking ability to navigate undefined practices and review complex situations for impacts to the organization. You have working knowledge of cGMP and/or medical device regulations and standards, and have experience conducting audits to assess risk and compliance alongside our internal and external partners. While we grow our Product Lifecycle Management, Systems, Business Operations, and Product Release teams, we are excited to grow your career with potential learning and travel opportunities, and have the opportunity to expand your knowledge of New Product Introduction (NPI).

Duties and Responsibilities

• Represent QA for cross-functional projects, initiatives, and meetings, with an ability to critically assess high level processes and provide recommendations
• Independently conduct and complete assigned audits, investigations, and propose remediations
• Identify compliance and process issues or gaps, and proactively collaborate with partners
• Review, verify and process of QMS records to ensure compliance to QMS standards such as ISO 9001/13485/relevant GMPs and established procedures
• Coach and mentor other internal team members, with the empathy to serve as an educator to those without a Quality background

Knowledge and Qualifications

• Bachelor's degree in a related field, with a minimum of six years of experience within a Quality biotechnology or pharmaceutical environment
• Strong ability to make decisions based on regulatory, corporate, and customer requirements and ensure the course of action suggested is based on a comprehensive judgment that is supported by data
• GMP QA experience is an absolute must
• Lead auditor experience and NPI experience would be a favorable asset
• The ability and eligibility to travel once a quarter internationally for work may be required

#Nonbench #LI-Hybrid STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as ?Scientists Helping Scientists? ? standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada. This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities. STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada?s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact. As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors. NOTE: STEMCELL?s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process. To apply, please select the ?Apply? button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.