Senior Professional Quality Assurance

Versiti Indiania, Inc • Dayton, OH • 7h ago

Responsibilities

Core Quality Responsibilities Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulationsand standards. Identify and develop quality system improvements. Integrates continuous improvement practices adopted by Versiti into quality systems, education, andimprovement activities. Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions. May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for compliance as required. May review regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management. May 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. * Reviews events to assess impact to products/test results.

Specific Senior 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. May be responsible for leading/mentoring junior level Quality personnel in daily activities. * 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

Master's Degree preferred

Experience

4-6 years 5+ years of experience in related field required

1-3 years 3+ years of experience with a master'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

Advanced knowledge in a specialized field and broad knowledge of several related disciplines within a function required

Involves the use of broad theoretical knowledge or advanced knowledge of a highly specialized field and their interrelationships required

Understands the interrelationships of different disciplines, directs the application of existing principles, and guides development of new policies and ideas required

Focuses on providing detailed analyses and applying results to improve business operations required

Requires advanced knowledge and application of external standards and regulations that impact related disciplines. required

Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) required

Knowledge of using

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