Raleigh, North Carolina, United States (On-site)
Job description
The Quality Assurance Specialist I is responsible for implementing and managing an ongoing quality management program that ensures the products and services the company provides is fit for purpose, is consistent and meets both Kryosphere Standard Operating Procedures (SOPs), Client Specifications, and external and internal regulatory requirements.
Role and Responsibilities
- QA review incoming client material and completed inventories
- QA review, approve, and email clients’ job folders
- QA review and release client material for transfer, shipment, and destruction
- QA review and approve validation documentation and other facility forms
- QA review clinical kits components/labeling, labeled components, and shipment of kits
- Participate in internal audits
- Client reports
- Special projects
- Demonstrates compliance with all Kryosphere SOP’s, administrative policies & procedures, and governing authorities’ regulations at all times
- Competently and safely works and handles potentially infectious material while following all prescribed OSHA blood borne pathogen guidelines.
- Able to understand and demonstrates at all times client confidentiality and adhere to HIPAA regulations. • Demonstrates a high level of knowledge of Quality Management principles and laboratory and pharmaceutical regulatory compliance.
- Collaborates effectively with Operations personnel and Management.
- Additional roles and responsibilities described below under essential job functions.
Qualifications and Education Requirements
Any one of the following: BS/BA Degree in a life science, healthcare, or quality management discipline, or previous 3-5 years equivalent education or experience in a similar biological sciences or related discipline. Minimum of 1 year biorepository work experience and previous experience in a quality assurance/management position preferred.
Preferred Skills
- Demonstrates innovative leadership and acts as a role model for all other team members.
- The ability to communicate clearly and professionally through both oral written channels. Understanding of daily repository scientific and clinical operations, regulations and terminology is highly desirable.
- Exceptional work organization and time management.
- Strong computer skills essential. LIMS experience.
- Knowledgeable of quality management systems and principles, as well as quality and statistical report preparation