Quality Assurance Specialist

Location: Virginia Beach, Virginia (Sabre)

Department: Quality Assurance

Job Type: Full-Time

Shift: Day shift; Monday-Friday, hours may varyClinical Classification: Non-Clinical

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:

The Quality Assurance Specialist performs various quality and administrative related functions in support of department management. Reviews all donor chart related documentation for birth tissue, clinical, non-clinical donors, and research donors to ensure accuracy, quality, and completeness of donor chart documents in accordance with FDA regulations, AATB Standards, LifeNet Health SOP, and research project requirements. Perform tasks associated with tracking and documenting final disposition of tissues. Serves as the primary Quality Assurance resource for research stakeholders. Assists with metric reporting to include Power BI dashboards. Analyzes and translates data especially as it relates to research projects. Participates in special projects, process improvement initiatives, and acts as a training preceptor when needed.

What you’ll do:

• Performs all aspects of the donor chart review process including but not limited to obtaining donor chart information, performing technical review to determine acceptability of tissue, and determining disposition of clinical, non-clinical, and research donors, according to defined protocols, in accordance with FDA regulations, AATB Standards, LifeNet Health SOP, and research project requirements, as applicable. Reviews documentation for accuracy and completeness. Determines readiness of the record for progression to next step of review process using defined protocols to meet production, distribution, and researcher needs. Performs all required database documentation including documentation of biospecimens recovered for research development, product development, and the advancement of science and medicine. Performs SAP entries for usage decisions and/or movement of tissues as authorized, following suitability determinations. Reviews recovery partner documents, as needed to ensure compliance.
• Acts as the key Quality Assurance resource for donation partners, and internal and external stakeholders as it relates to Research and the support of Life Sciences. May also act as the Recovery Partner Liaison for Clinical Recovery Partners. Works closely with interdepartmental groups, fostering a team-oriented work environment, prioritizing customer needs. Use timely, appropriate, and effective communication for internal and external customers.
• Initiates and reviews nonconformances; completes investigations, performs quality hold placement and removal, as assigned.
• Utilize data analytics to manage regular reporting of key performance indicators as it pertains to research project management. Provides reports to key leadership. Identifies trends, reviewing performance against department expectations. Collaborates with department leadership to maintain optimal performance.
• Serves as preceptor for department and new hire training. Monitors trainee progress and reports to department leadership. Develops and updates training programs and materials for Quality Assurance. Ensures use of appropriate learning style approaches.
• Participates in and leads continuous improvement initiatives.

What you’ll bring (Minimum Requirements):

• High School Diploma or GED required; advanced degree in biological sciences, preferred.
• Four (4) years’ experience in tissue banking, medical devices, research, biologics, or related healthcare field (with high school diploma)OR 0 years’ related experience (with BA, BS, or other advanced degree)
• Completion of LEAN Six Sigma White Belt or higher required
• Two (2) years data analytics experience preferred.
• Certified Tissue Bank Specialist (CTBS) achieved preferred.
• Four (4) yearsquality assurance experience preferred.

Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won’t find another company with a culture as strong as ours.

• 403(b) and Profit Sharing Plan
• Affordable medical, dental, and vision coverage
• Corporate-sponsored events
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
• Tuition reimbursement
• Personal career, leadership, and skill development opportunities
• Wellness Program (gym reimbursement, monthly wellness seminars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• Dedicated and passionate co-workers

We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.