Quality Specialist

Responsibilities:

· Promote adherence to GMP, GDP, and regulatory compliance across all quality operations.

· Assist with the release of incoming raw materials, ensuring proper documentation and compliance.

· Support Quality Control (QC) and Analytical Research & Development (ARD) by reviewing, approving, and filing Certificates of Analysis (CoAs).

· Oversee clinical-phase manufacturing from a quality perspective, including batch record issuance, line clearances, and maintaining an active QA presence on the production floor.

· Conduct inspections and quality checks on raw materials, components, and in-process materials.

· Review batch documentation, manage deviations, investigations, and change controls, and support the disposition process for Intermediate and Drug Product (DP).

· Manage the document lifecycle, including initiating, revising, approving, and distributing controlled documents.

· Ensure documents meet compliance standards, maintaining consistency in formatting, completeness, and adherence to templates.

· Maintain training programs, including tracking employee training records and maintaining department curricula.

· Actively participate in continuous improvement initiatives to enhance quality systems and compliance processes.

Qualifications:

· Bachelor’s degree (BA/BS) in a science-related field.

· 2-6 years of experience in quality roles within pharmaceutical, biotech, or medical device industries.

· Strong knowledge of GMP, GDP, and regulatory requirements for pharmaceutical development.

· Experience in Gene Therapy, Cell Therapy, or AAV manufacturing is highly preferred.

· Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, and Smartsheet.

· Strong attention to detail, problem-solving skills, and ability to manage multiple priorities.