Shift: Mon-Friday 8:15AM-5PM; hours may vary; nights, weekends, and on-call as needed
Travel: Up to 30% travel
LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.
How you will contribute to LifeNet Health’s success:
As Quality Systems Auditor, you will ensure internal quality audits are effective, on schedule, and meeting all regulatory requirements. This position supports the performance of desktop audits and surveys of tissue suppliers and intermediaries and may assist with conducting onsite or virtual audits of external partnering agencies upon request. This position supports the overall business operations by utilizing an analytical approach to problem resolution by conducting quality audits in accordance with internal SOPs, contracts, voluntary accreditation standards and required government regulations. This position also supports the overall implementation and maintenance of quality systems including activities such as conducting investigations, performing CAPA administrative functions, and supporting second/third party audits.
What you’ll do:
Performs all facets of internal quality audits, including plan development, initiation, observations/interviews, analysis of results, report compilation/distribution, presentation of results to auditees, approval and verification of corrective/preventive actions, and audit file maintenance.
Assists with the performance of tissue supplier audits and tissue distribution intermediary audits/desktop surveys.
Provides guidance and assistance to assigned partnering departments in LifeNet Health’s Zone Assessment Program.
Supports third party audits of LifeNet Health by government agencies, voluntary accreditation agencies and business partners as needed.
Leads projects with cross-functional teams and promotes problem resolution methods, such as 8D, to solve problems throughout the organization. Participates on project teams as assigned.
Creates and revises Standard Operating Procedures consistent with QSR/GTP, AATB, and ISO requirements.
Reviews elements of CAPA investigations for completeness and accuracy, verifies effectiveness of corrective actions, and works with key stakeholders to ensure related documentation adequately resolves the related issue(s); Serves as a QS technical resource/SME for CATSWeb related activities and provides training as required.
What you’ll bring (Minimum Requirements):
Bachelor’s Degree received from a four-year accredited college (In lieu of degree, see experience)
Experience in quality or operations related activities in tissue banking, blood banking, medical device, clinical trial, or pharmaceutical (2 years’ experience required with degree; 6 years’ experience required without degree)
Bachelor of Science in Business Management, Public Health, Quality Engineering, Natural Sciences or Allied Health field, preferred
2 years Professional work experience in quality or operational auditing, preferred
These would be nice too (Knowledge Skills and Abilities):
Auditing: Demonstrates understanding of quality auditing concepts; Ability to effectively apply auditing concepts to both familiar and unfamiliar areas of focus preferred
Analytical Thinking: Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
Industry regulations, standards, and guidelines: Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable; Familiarity with applicable tissue banking/medical device related regulations, standards and guidelines 21 CFR 1271, 21 CFR 820, ISO 13485, AATB Standards preferred
Communication: Demonstrates excellent verbal and written communication skills; Ability to effectively communicate with a variety of internal and external customers preferred
Problem Resolution: Demonstrates ability to anticipate and critically think through problems; Proficient with advanced problem resolution tools 8D, Ishikawa preferred
Technical Writing: Able to create and revise documents, presentations and training materials according to established requirements; Proficiency with word processing, publishing and other relevant software types Microsoft Office, Adobe Pro preferred
LifeNet Health is a non-profit, global leader in regenerative medicine and life sciences. We fulfill our life-changing mission by focusing our efforts in three core areas: LifeNet Health’s Organ Procurement Organization saves more than 500 lives annually through transplantation. LifeNet Health Biologics provides more than 700,000 tissue implants globally each year for use in a vast range of surgeries. LifeNet Health LifeSciences offers innovative human cell- and tissue-based solutions for biomedical researchers developing the next generation of therapies. Through it all, we remain steadfast in our commitment to honoring the donors and donor families whose selfless generosity makes our work possible.