Job Description Summary

As a Senior QA Associate, you will contribute to upholding quality standards and regulatory compliance by performing key quality activities, maintaining quality documentation, and recommending continuous improvement initiatives. You will apply independent judgment to evaluate complex quality issues and implement effective solutions using current industry practices and methodologies. Through your expertise, you will help ensure that all products meet specified quality requirements and regulatory standards, contributing significantly to STEMCELL's commitment to quality and compliance.

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

• Bachelor's 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

#LI-KK1 #LI-Onsite

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.

The annual salary for this job ranges from:
$72,700.00 - $98,300.00

STEMCELL determines an individual's 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 policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.

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