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Responsibilities

Core Quality Assurance Specialist Responsibilities * Supports

Supervisor/Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. Identify and develop quality system improvements. May integrate continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. May support internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. Prepares charts, tables, etc. to analyze quality metrics. May communicate results and actions of quality metrics. May review, approve and/or execute validation plans, corrective action plans associated with events, and other required documents for compliance as required. Supports operations with review of proposed changes in methods, manufacturing, or instrumentation. May support with the development, compilation, and submission of regulatory submissions as required. Review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions. May support Manager with the review of events to assess impact to products/test results. Acts a resource for regulatory and quality matters.

Specific Quality Assurance Specialist Responsibilities * Identify

emerging events in the applicable service line(s) and assess product, donor, patient, and/or customer impact and risk. Conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems. Perform review of nonconforming products. Participate in decisions to determine product suitability for use, distribution, or recall. Support organizational projects from a quality perspective and complete assigned tasks in a timely manner. Ensure applicable service lines comply with the requirements of the quality management system, as applicable. \ Serve as back up support to other Quality Assurance Specialists. \ Actively participate in training, continuous improvement activities and Lean initiatives. * Perform other duties as assigned by direct supervisor or Quality leadership.

Performs other duties as assigned

Complies with all policies and standards

Qualifications

Education

Bachelor\'s Degree (in Clinical Laboratory Science, life sciences,

engineering with science minor, scientific discipline, or allied health science discipline) required

Associate\'s Degree (in Clinical Laboratory Science, life sciences,

engineering with science minor, scientific discipline, or allied health science discipline) required

Experience

4-6 years experience required in related field with associate degree

required

1-3 years experience required in related field with bachelor\'s

degree required

Experience in QMS, QA, QC, or Quality Auditing preferably in an

environment such as blood banking, pharmaceutical, medical devices, or a hospital preferred

Knowledge, Skills and Abilities

Understands and applies the principles and practices in a recognized

professional field requiring extensive academic preparation and experience

Likely to be an experienced professional qualified in a specific

field, or may have experience in a complex technical area

Determines and implements a course of action based on guidelines and

may modify processes and methods as required

Generally, requires knowledge of company policies, practices, and

procedures

Ability to read and interpret applicable regulations and standards

required

Knowledge and application of external standards and regulations

preferred

Ability to use professional concepts and company\'s policies and

procedures to solve a variety of problems works on problems of moderate scope required

Strong communication and business acumen skills required

Proficiency in Microsoft Office

Possess strong attention to detail

Knowledge of GxP requirements such as Good Documentation Practice

(GDP) and FDA Quality System Regulations (QSR) required

Licenses and Certifications

Quality certifications (i.e., ASQ CQA, ASQ CQE) preferred

Tools and Technology

Personal Computer (desktop, laptop, tablet) required

General office equipment (computer, printer, fax, copy machine)

required

Microsoft Suite (Word, Excel, PowerPoint) required

Versiti Blood Center of IL

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