Component Lab Operations Specialist

Nebraska Community Blood Bank (NCBB.ORG), a division of Innovative Blood Resources (www.innovativebloodresources.org), has been saving and sustaining lives since 1968. We are dedicated to connecting people who need life-saving blood with generous volunteers who give. Operating 4 donor centers and conducting dozens of blood drives each month, we are proud to be an independent nonprofit that supplies over 20 area hospitals and clinics with life-saving blood-from our community, for our community.

In addition to demonstrating competence in the responsibilities of the Technician (Tech) I, II and III positions, the Operations Specialist (OS) provides technical expertise in the Component Laboratory (CL) by solving problems, ensuring that equipment is maintained and repaired, providing training to staff, reviewing records and quality control, cellular therapies, monitoring process control and coordination of protocols. Additional responsibilities include performing competency assessments, assisting in SOP revisions and assisting with organizational projects. Staff in this position may qualify as a Technical Consultant for CLIA regulated instrumentation if specific criteria are met. All work processes are performed and documented according to current Good Manufacturing Practices (cGMP) and within the guidelines of accrediting organizations (FDA, AABB, Green Cross, CLIA, etc.).

Employees will exhibit role model behavior, practice the IBR core values of respect, integrity, synergy, excellence and service that are in line with the mission of IBR. Teamwork, collaboration and professionalism with others in the department as well as the organization are also expectations of this position. Strong leadership is required of this position as well as reasoning, communication and decision-making skills.

Operation Specialist responsibilities include, but are not limited to the following:

Make decisions regarding product SQUIPP (with QRA guidance)
• Review manufacturing records and quality control records
• Track quality control results
• Assist in controlled document revisions
• Act as a key staff designee
• Train coworkers on CLT I, CLT II, CLT III and OS job responsibilities, as needed
• Collaborate on document revisions in MC
• Coordinate staff training and competency assessments
• Assist in preparation, coordination and execution of qualification, validation and verification protocols
• Coordinate research activities with the Research and Regulatory Affairs Supervisor
• Assist with deviation investigations and process control
• Appointment as a system super user, as needed
• Assist in compiling information related to CAPA's
• Enter CAP survey results online
• Exercise expertise and act as the point person in specialties such as quality control, equipment, training, cellular therapies, process control
• Direct daily workflow under the direction of the laboratory leadership
• Act as leadership designee and customer contact in the absence of laboratory leadership
• Create and modify lab scheduling in the absence of laboratory leadership

Other duties as requested

Education:

High school diploma or equivalent

Related Experience

3 years CL experience (1 year as a CTIII) and,

Completion of all Tech I responsibilities applicable for the site of employment and, Competence in Tech II responsibilities applicable for the site of employment and, Competence in Tech III responsibilities applicable for the site of employment,

- Or -

2 years CL experience including one year in the IBR CLT III position and 2 years clinical laboratory experience as CLS, MLT or MT

Preferred Qualifications

Education: Bachelor or Associate degree in Medical Technology, Clinical Laboratory Science, or general science

Experience:

Demonstration in one or more Operations Specialist responsibilities Experience working in a component production or clinical laboratory

Laboratory manufacturing experience using cGMP Customer service

Proven attention to detail with minimal errors Proven leadership skills