Senior Associate, Quality Assurance

2 days ago

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Aspect Biosystems

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Developing bioprinted tissue therapeutics to transform the treatment of currently incurable diseases.

bioprinting • tissue engineering • regenerative medicine • therapeutic development

51 - 200

Description

• 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 document, design, process, and material related changes. • 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 carrying out risk assessments on core raw materials.

Requirements

• Education: Bachelor’s in biology, biomedical engineering, experimental medicine, biotechnology, or related discipline. • Professional Experience: 3 – 5 years of hands-on experience developing, or administrating GMP quality programs in biotech 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.

Benefits

• Equity • Comprehensive benefits package • Support for continuous learning and career progression