Provides key Beyond Birth program support to Hospitals and the StimLabs organization

• Participates in acquisition daily activities with weekend rotation for coverage.
• Suggests and implements improvements within the Beyond Birth (BB) program, Quality System and department.
• Acts as an acquisition representative within the organization, raising awareness for high standards and education.
• Contributes to the development and health of medical partners, hospitals, and Stimlabs employees.
• Assists or lead on a variety of projects as designated by Beyond Birth Management.
• Member of StimLabs Internal Audit Team.
• Conducts all activities and documentation related to Beyond Birth Quality Assurance and Quality Control.

Essential daily operations of the Beyond Birth department includes but not limited to:

• Provide education about donation, get informed consent to donate, and conduct risk assessment interviews.
• Coordinate with hospital and physician group staff to ensure completion of donor records
• Review donor records for donation eligibility.
• Prepare and submit serology requisition and ship vials to laboratory partner.
• Package donated tissue in accordance with standards for delivery to StimLabs
• Ensure donor records are timely, accurate and within compliance with Stimlabs’, FDA and AATB policies, procedures and guidance’s.
• Deliver and receive tissue at StimLabs processing facility.
• Appling aseptic technique for donor storage
• Assist with training of new employees as well as hospital personnel.
• Acquire additional donor information or clarification as requested by Medical Director
• Team and individual prioritization of duties and tasks as necessary to ensure assignments are completed in a timely manner.
• Review current procedures and identify opportunities for increased efficiency.
• Coordinate responses and resolutions to issues with appropriate internal and external parties.
• Maintain and promote positive and professional working relationships with associates and management.
• Perform related duties as assigned by management.
• Assists and collaborates on development of Standard Operating Procedures, Work Instructions, Forms, sampling plans, and specifications.
• Collaborates with Donor Services to complete investigations and documentation.
• Assists with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by Beyond Birth Management.

EDUCATION/CERTIFICATION

• Bachelor’s degree in a technical/relevant field, with at least three to five (3-5) years of Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience.

REQUIRED KNOWLEDGE AND QUALIFICATIONS

• Knowledge and understanding the tissue donation process (donor, regulatory requirements, eligibility, logistics, etc.)
• Experience interfacing with patients
• Experience working in hospital / healthcare setting
• Strong interpersonal skills
• Strong organizational skills; attention to detail
• Ability to communicate effectively both orally and in writing
• Ability to multitask
• Ability to work closely with internal and external colleagues
• Ability to represent a positive and professional image with internal and external colleagues
• Ability to assist team leads and managers in reporting, trending, and on-going training as required
• Experience with the tissue/ organ / blood donation process

Preferred Qualifications:

• Minimum 2 years related experience (tissue, blood donation/acquisition)
• Functional knowledge working within a cGMP regulated environment.
• Understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations.