Senior Professional Quality Assurance

Versiti, Inc.•Dayton, OH

2d•Hybrid

About The Position

This role provides advanced specialist support in the corresponding quality field and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines. Works to support the development and communication of the overall Versiti quality program. Ensures that all Versiti service lines receive guidance and support from Quality to enable them to obtain organizational goals.

Requirements

Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required
4-6 years 5+ years of experience in related field required
1-3 years 3+ years of experience with a master's degree required
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 professional concepts and company policies and procedures to solve a variety of problems works on problems of moderate scope. required
Exercises independent judgment within defined procedures and practices normally receives general instruction required
Strong communication and business acumen skills required
Proficiency in Microsoft Office required
Possess strong attention to detail. required
Personal Computer (desktop, laptop, tablet) required
General office equipment (computer, printer, fax, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required

Nice To Haves

Master's Degree preferred
Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred
Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, ASQ CQE) preferred

Responsibilities

Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards.
Identify and develop quality system improvements.
Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement 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.
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