Senior Donor Services Specialist

Company: StimLabs
Location: Roswell
Posted on: June 12, 2021

Job Description:

KEY DUTIES AND RESPONSIBILITIES

Provides key Donor Services support to the StimLabs organization

• Participates in Donor Services daily activities.
• Suggests and implements improvements within the Donor Services System and department.
• Acts as a quality representative within the organization, raising awareness for quality standards and education.
• Contributes to the development of donor services-related infrastructure for new processes.
• Assist or lead on a variety of projects as designated by Donor Services Management.
• Member of StimLabs Internal Audit Team.
• Conducts all activities and documentation related to Donor Eligibility.

Participates in daily operations of the Donor Services department including but not limited to:

• Leads the review of donor eligibility documentation and associated release activities to ensure compliance with applicable procedures.
• Performs and documents incoming inspections of donor tissues to ensure compliance with product specifications and applicable regulations and requirements. Communicates with tissue partners to obtain additional information as needed.
• Leads and collaborates on development of Donor Services related Standard Operating Procedures, Work Instructions, and Forms.
• Assists and implements when applicable, with Donor Services process validations.
• Leads in the collection of donor data and trending and presents data summary reports to Donor Services Management in addition to providing data to Quality for Management Review.
• Leads and performs the donor information sharing, rejection notices, and donor chart corrections process.
• Performs review of donor charts, infectious disease testing results, procurement culture results, and prepares the donor chart for final eligibility review to the StimLabs Medical Director.
• Assists with investigations and documentation related to Donor Services of CAPAs, Deviations, Nonconformance Reporting, and Complaints, as directed by Donor Services Management.
• Assists in releasing batch records for final product distribution.
• Trains peers on processes within the Donor Services team and assists with adherence to Standard Operating Procedures and Work Instructions.
• General administrative tasks such as scheduling, filing, organizing etc.
• Support inspections and audits from regulatory agencies, as needed.
• Other Quality functions as designated and trained by Management (e.g., Tissue Utilization Records, Environmental Monitoring, Supplier File Maintenance, Quality Review of records etc.).
• Assists with the Supplier Qualification and Control program for Recovery Establishments/tissue partners.
• When applicable, performs as needed, the donor tissue acquisition process including but not limited to:
  • Hospital referrals
  • Collaborating with physicians on StimLabs protocol for acquiring tissues.
  • Collecting donor authorization/donor informed consent, performing donor risk assessment interview/medical social history questionnaire, offering services to donors/birth mothers
  • Aseptically acquiring, packaging, and shipping donated tissues

EDUCATION/CERTIFICATION

Bachelor's degree in a technical/relevant field, with at least three to five (3-5) years in donor chart review experience in a hospital, medical facility, medical device, biologic or tissue banking FDA regulated facility; or an appropriate combination of education, certification, and work experience.

REQUIRED KNOWLEDGE

Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations. Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment required. Experience in tissue banking preferred but not required.

Job Type: Full-time

Pay: From $65,000.00 per year

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• 3-5 years minimum donor chart review

Work Location:

• Roswell, GA

Work Remotely:

• No

COVID-19 Precaution(s):

• Remote interview process

Who we are

StimLabs is a regenerative medicine company guided by our desire to innovate and create optimized healing solutions. By bringing together a unique set of skills across tissue engineering, pharmaceuticals, and medical devices, we're reimagining what's possible in regenerative medicine. Our staff, our quality system, and our physical workspace were all meticulously selected with the future in mind.

StimLabs is home to some of the top tissue engineers, inventors, and thought-leaders in the healthcare industry. Combined, these individuals have more than 100 years of experience in healthcare.

Our Culture

We're looking for like-minded individuals who are forward thinking, hard-working, and self-motivated. We pride ourselves in hiring genuine people who are able to work collaboratively towards our vision. We have a united culture where everyone from quality and operations to marketing and product development works together as a team.

StimLabs is an Equal Opportunity Employer

Keywords: StimLabs, Roswell , Senior Donor Services Specialist, Other , Roswell, Georgia