The Community Blood Center is hiring a Quality Assurance Specialist to join our Quality Assurance Team.
Under the supervision of the Quality Assurance Manager, this individual will be involved in the development of quality metrics and key performance indicators for the blood center, analyzing and identifying trends in deviation/incident data to report to department management and assisting with supplier qualification activities and the maintenance of the qualified supplier list.
- The review and approval of equipment, blood product and computer system validations including installation qualification, operational qualification and performance qualification, participation in regulatory/accrediting agency inspections, preparation for and performance of internal audits with subsequent report to Center management
- Responsible for entering FDA reportable errors into the applicable computer application and compiling the appropriate paperwork
- Participating in corrective and preventive action teams
- Assisting with investigation and root cause analysis
- Verifying that corrective actions are implemented and effective
- Understand and apply principles of quality management practices to the monitoring and improvement of the blood center operations
- Assist with the development of performance improvement initiatives and implementation processes
- Ensure compliance with all applicable state and federal laws and regulations and standards of the accrediting/certifying agencies as they relate to blood centers
JOB QUALIFICATION REQUIREMENTS:
- Bachelor’s degree preferred. Experience in medical technology or a clinical allied health field is preferred.
- 1-3 years of experience in a blood center, biologics, pharmaceutical or medical industry manufacturing environment with base familiarity of quality assurance practices, training, and federal regulatory practices is preferred.
- Excellent organizational, oral, and written communication skills.
- Strong analytical and problem-solving skills
- Strong, flexible interpersonal skills
- Skilled in observation of operational tasks
- Skilled in documentation review with special emphasis on details
- Computer skills with emphasis on word processing and database software
Employee may occasionally be required to lift objects or materials weighing up to 25 pounds.
Submit your application to be considered for this position: https://secure.entertimeonline.com/ta/8026.careers?ApplyToJob=302161745
The Community Blood Center
4406 W. Spencer St.
Appleton, WI 54914
The Community Blood Center is an EEO/AA/M/F/Vet/Disability Employer