Quality Assurance Specialist

Responsibilities:

• Review and approve client materials, validation documentation, facility forms, and completed inventories in alignment with SOPs, client specifications, and regulatory requirements.
• Oversee the release, transfer, shipment, and destruction of biological materials, ensuring accurate labeling and documentation.
• Participate in internal audits, generate client reports, and support special projects to maintain compliance and continuous improvement.
• Ensure strict adherence to safety regulations when handling potentially infectious or biohazardous materials, following OSHA and HIPAA guidelines.
• Collaborate effectively with Operations and Management teams to maintain high-quality standards and timely workflows.
• Utilize LIMS and other quality management tools to track, document, and communicate QA outcomes efficiently.

Requirements:

• Bachelor’s or associate degree in life sciences, healthcare, quality management, or a related field—or equivalent combination of education and experience.
• One year, or more, of biorepository or laboratory experience, with a minimum of 1–2 years in a QA or quality management role preferred.
• Strong understanding of quality management systems (QMS), GMP regulations, and quality assurance principles.
• Proficiency in LIMS and other computer systems; ability to prepare quality and statistical reports is highly desirable.
• Exceptional organizational, time management, and communication skills, with the ability to maintain confidentiality.
• Demonstrated ability to collaborate, lead by example, and support operational excellence in a fast-paced laboratory or pharmaceutical environment.