Quality Assurance Specialist

About the role

This role sits within a gene therapy biopharmaceutical company's Quality Assurance organization, providing oversight and auditing of clinical and preclinical laboratory studies to ensure regulatory compliance.

Responsibilities

• Assess and assure study, project, and process compliance with protocols and applicable regulations through audits.
• Audit studies, processes, reports, records, and data for accuracy and compliance, following up on audit findings.
• Perform in-process inspections of nonclinical study phases and assay methods.
• Act as a technical resource for compliance-related issues based on knowledge of regulations and SOPs.
• Support other quality assurance duties as assigned by management.

Requirements

• Bachelor's degree in a health care or relevant scientific field.
• 5 or more years of relevant industry experience.
• Knowledge of GCLP, GLP, and 21 CFR Part 11 requirements and laboratory standards.
• Audit experience required.
• Strong knowledge of immunogenicity (NAb and TAb) and ddPCR assays.

Preferred / Bonus Knowledge

• Knowledge of GCP regulations.
• Experience working in a matrixed, cross-functional team environment.