Senior Quality Assurance Associate, Systems

Job Description Summary

Job Description

Duties and Responsibilities

• Perform key quality activities focusing on nonconformance and corrective and preventive actions (CAPA) systems while supporting supplier corrective action requests (SCAR) change control audit and document management to maintain quality standards and ensure regulatory compliance
• Conduct and facilitate investigations using industry standard methods for root cause determinations and identification of meaningful corrective and preventative actions
• Conduct internal and external audits to assess compliance with applicable standards regulations directives and organizational policies
• Partner with cross-functional teams to ensure Quality Management System (QMS) compliance analyze quality data (e.g. inspections testing audits CAPA metrics and quality key performance indicators) and recommend process improvements
• Maintain accurate complete and compliant quality documentation including policies procedures records and quality system activities in accordance with regulatory requirements

Knowledge and Qualifications

• Bachelors Degree in Life Sciences (e.g. Chemistry Biology) or related field with 2-6 years of relevant QA experience
• Knowledge of QMS including nonconformance CAPA SCAR change control and document control
• Solid understanding of regulatory requirements and industry standards including ISO 9001 ISO 13485 CE medical/IVD device directives and cGMP with the ability to interpret and apply technical documents procedures and regulations
• Demonstrated ability to coordinate QA responsibilities maintain accurate quality and regulatory documentation manage multiple priorities in a fast-paced environment and apply strong organizational project and time management skills
• Excellent communication technical report writing presentation interpersonal and cross-functional collaboration skills with a self-motivated independent work ethic and a willingness to learn and take on new responsibilities

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STEMCELL Technologies is a privately owned Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality we are a company of Scientists Helping Scientistsstanding by our customers to provide the outstanding products technical support and training they need to advance their research. 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 accessory products and services. Through our many regional offices as well as our distribution centers in Vancouver Seattle Grenoble and Singapore we deliver our innovative specialized products to more than 100 countries. With over 1800 employees globally most with scientific or engineering degrees STEMCELL is proud to be the largest biotechnology employer inCanada.

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 Canadas 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.

The annual salary for this job ranges from:

STEMCELL determines an individuals pay within the range based on multiple factors including experience education job-related skills and equity within the team or organization. For jobs that are eligible for sales incentives the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company addition to base salary STEMCELL offers a comprehensive total rewards package including health benefits retirement savings and more.

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