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Senior Professional Quality Compliance

3 months ago

Milwaukee, United States Versiti Inc. Full time

Overview:

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:

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.

Responsibilities:
  • Core Quality 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 develop, compile, and submit regulatory submissions as required. * 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 Compliance Specialist Responsibilities * Perform internal audits per the approved Internal Audit Schedule, and lead a team of quality auditors, when needed * Evaluate production processes for compliance with quality requirements * Support audit team in developing audit reports; present audit reports to top management, as needed * Perform tracking and trending of data for the quality management system elements * Participate in the compilation of Quality Management Review * Conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems. * Support and/or lead 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 the Supervisor, Quality Compliance, and other Quality Compliance Specialists. * Participate and/or lead training, continuous improvement activities and Lean initiatives. * Support external audits, as applicable * 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 of experience in related field required
  • 4-6 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 quality, compliance, regulatory affairs, etc. and broad knowledge of several related disciplines within those functions
  • Involves the use of broad theoretical knowledge or advanced knowledge of a highly specialized field and their interrelationships
  • Understands the interrelationships of different disciplines, directs the application of existing principles, and guides development of new policies and ideas
  • Focuses on providing detailed analyses and applying results to improve business operations
  • Requires advanced knowledge and application of external standards and regulations that impact related disciplines.
  • Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR)
  • Knowledge of using professional concepts and company policies and procedures to solve a variety of problems works on problems of moderate scope.
  • Exercises independent judgment within defined procedures and practices normally receives general instruction
  • Strong communication and business acumen skills
  • Proficiency in Microsoft Office
  • Possess strong attention to detail.

Licenses and Certifications

  • Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, 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
  • Quality Auditor tools and techniques required


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