We are seeking a Quality Assurance Specialist to strengthen and oversee our quality assurance development. You will pioneer and execute quality assurance activities associated with clinical Good Manufacturing Practices (GMP) of our bioprinted cell therapies. With a passion for optimization, you will also drive continuous improvement of our manufacturing and quality systems by developing, applying, revising, and maintaining quality metrics.

Responsibilities

• Support in development of internal QA processes and procedures and implementation of the company’s Quality Management System (QMS).
• Maintain and provide document control support.
• Assist in development of training content for QA processes, maintain training and certification requirements for the position.
• Identify and evaluate issues and/or gaps in processes and documentation and propose effective solutions to remediate.
• Provide QA expertise on change management, and support implementation of documents, design, process, and material related changes.
• Collaborate closely with R&D teams from the early development phases to embed quality standards directly into product designs, technical documentation, and underlying engineering processes
• Support the internal vendor qualification program by ensuring vendor documents are up to date and compliant.
• Be the quality assurance and documentation expert and support cross-functional groups on:
• Reviewing study protocols and reports
• Creating, reviewing, approving, and implementing SOPs, Policies, forms, and other controlled documents
• Reviewing data for completeness
• Completing root cause analysis/ investigations and implementing appropriate corrective and preventive actions.
• Review executed batch records to ensure compliance with Good Documentation practices and procedures; communicate and resolve discrepancies with the cross-functional teams.
• Collaborate routinely with the CMC and QC teams during processing, bioprinting and testing, ensuring buy-in and ownership of our quality program.
• Assist in the development of critical raw material specifications and review and approve incoming raw materials.
• Support in the development and implementation of critical CMC equipment qualification.
• Assist in Risk Management by conducting risk assessments on core raw materials.
• Other duties as assigned.

Qualifications & Experience

• Education & Experience: You hold a Bachelor's degree or Master’s degree inBiology, Biotechnology or another relevant discipline and 5-7+ years of hands-on experience developing, or administrating GMP quality programs in biotech, medical device, or pharmaceutical environments.
• Regulatory Expertise: Demonstrated knowledge and application of industrial regulations including those of FDA, EMEA, and other authorities related to Biologics and/or Pharmaceuticals. Experience with medical device regulations is a plus.
• Detail-Oriented: You have outstanding attention to detail as well as process rigour. You take pride in your work and strive for excellence.
• Go-Getter: You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary, and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.
• Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.

The hiring range for this role is $73,863 - $92,329, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.