Responsibilities:

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

Requirements:

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