Job Description

Make a difference in the lives of others by helping give the gift of sight!

VisionGift (VG) is a non-profit organization founded in 1975 by Lions Clubs of Oregon, which recognized the need for an eye bank to provide ocular tissue for transplants, research and medical education.

Since its inception, over 65,000 people have received the gift of sight from tissue procured and screened by VisionGift, which works closely with transplant surgeons. Additionally, ocular tissues have been utilized for valuable research projects and surgical training.

Please visit for more information on our organization.

The Quality Program Specialist (QPS) is responsible for carrying out day-to-day activities of the VG

Quality Program and/or contracted partner Quality Programs under the direction of the Quality Program

Manager.

ESSENTIAL FUNCTIONS / ASSIGNED RESPONSIBILITIES AND DUTIES

• Perform audits of VG manufacturing processes per established schedules to ensure compliance with VG SOP.
• Participate in administration of document control system, including managing documents shared with other agencies.
• Perform initial and ongoing vendor qualifications for companies performing manufacturing steps for VG.
• Complete initial and ongoing State, Federal, and international registrations, or licensure.
• Interpret postoperative data and determine where additional investigation into potential adverse reactions is needed.
• Investigate reported adverse reactions and submit findings for review to Management and Medical Director for final tissue imputability determination.
• Perform external reporting to State, EBAA, and FDA, as applicable, of adverse reactions and communicate outcomes with consignee(s).
• Participate in CAPA related activities (including customer complaints, deviation discoveries, DFPs, etc.).
• Be available to staff to assist with compliance and quality questions or problems.
• Participate in continuous improvement efforts including identification of processes needing improvements and taking the lead to initiate those improvements when necessary.
• Assist with external audits as needed (e.g. EBAA site inspections, FDA inspections, customer inspections)
• Maintain a professional demeanor and interact well with others.
• Other assignments as indicated by Supervisor.

Education

Bachelor\'s degree in science is preferred. Experience in medical/healthcare field may substitute for science-related degree.

Experience/Skills

• 1+ year working at VG, or 2+ years working with a Quality System, preferably in tissue banking or
• blood banking fields
• Experience with CAPA structures and root cause analysis preferred
• Experience with process, compliance, and department audits preferred
• Working knowledge of EBAA Medical Standards and FDA CGTPs preferred
• Strong organizational skills and attention to detail
• Strong analytical, critical thinking, and problem-solving skills
• Reliable and timely decision maker
• Proficient PC application skills, including knowledge of Microsoft Office package, Windows and email
• systems required. Familiar with Q-Pulse, environmental monitoring, and iTransplant software
• preferred
• Excellent communication skills and the ability to work with all levels of the company
• Positive attitude and willingness to work pro-actively and with a team

Work Environment and Physical Demands:

• Ability to read/visually comprehend reports, computer screens, etc.
• Perform tasks requiring manual dexterity such as processing paperwork, filing, stapling, sorting, typing/using computer mouse, etc.
• Sit or remain in a stationary position for extended periods of time.
• Subject matter is sensitive and requires discretion.
• Minimal travel may be required.

Benefits

• Medical, dental, and vision employee premiums paid in full
• Paid parental leave after 1 year of service
• Time off policies: 3 weeks PTO, 7 paid holidays, 1 Floating Holiday and 1 DEI holiday
• Employer-funded HRA
• $20,000 employer-paid life insurance policy
• Employer-paid short-term disability
• Voluntary benefits and more!

NOTICE TO APPLICANTS:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet 100% of the qualifications listed in the job post. We are more interested in finding the best candidate for the job, and encourage you to apply, even if you do not meet every qualification listed. If you are unsure if you meet the qualifications of this role please email hr@visiongift.org to discuss your application.

Please read this job description carefully and ask for clarification if you have difficulty understanding the functions of this job.

Please describe any accommodations that you need in order to perform this job.

PM19

PI227911838

VisionGift