Senior Quality Assurance Associate

Job Description Summary

Job Description

Duties and Responsibilities

• Provide comprehensive Quality oversight of GMP cleanrooms manufacturing processes and products to ensure continuous compliance with regulatory standards

• Perform Line Clearance between batching campaigns and supporting activities and providing real-time guidance to promptly resolve quality and compliance issues

• Execute and oversee key Quality Management System activities including supporting change controls maintaining robust documentation and leading in the identification investigation and resolution of non-conformances

• Perform technical reviews of Standard Operating Procedures work instructions and validation documents to guarantee accuracy completeness and alignment with regulatory requirements

• Support site audit readiness by continuously monitoring manufacturing compliance while identifying and implementing process improvements to aid compliance and operational efficiency

Knowledge and Qualifications

• Bachelors Degree in relevant field with less than 2 years Quality Assurance and/or regulatory and process improvement experience in the biotech industry or equivalent

• Knowledge of regulatory requirements and industry standards including ISO 13485 CE medical and IVD device directives and cGMP with the ability to interpret and apply technical documents procedures and regulations

• Strong critical thinking analytical and problem-solving skills

• Ability to coordinate and execute Quality Assurance responsibilities manage multiple priorities in a fast-paced environment and demonstrate strong project and time management skills

• Excellent communication technical report writing presentation and interpersonal skills with a self-motivated approach independent work ethic and willingness to learn and take on new responsibilities

#LI-KK1 #Bench #Onsite

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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