Quality Compliance Professional

Versit; Indianapolis (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Versiti is seeking a Quality Compliance Specialist to support the Quality department in quality, compliance and regulatory affairs, acting as a liaison between the Quality team and other service lines. The role partners with service lines to provide quality input on projects and everyday tasks.

The successful candidate will help implement the Quality Plan, perform internal audits, track data for the QMS, and support Lean initiatives while ensuring adherence to GDP/QSR standards.

Qualifications

• 4–6 years experience in QMS, QA, QC, or Quality Auditing.
• Experience in blood banking, pharmaceutical, medical devices, or a hospital setting preferred.
• HS Diploma acceptable with relevant experience.
• GxP knowledge preferred (GDP and QSR).

Responsibilities

• Support Supervisor in executing the Quality Plan and ensure regulatory compliance.
• Identify and develop quality system improvements.
• Prepare charts and analyze quality metrics.
• Perform internal audits per schedule.
• Assist with data tracking for QMS elements.
• Participate in Quality Management Reviews.

Skills

Strong communication

Attention to detail

Regulatory knowledge

Education

Bachelor's Degree in Clinical Laboratory Science or related

Associate's Degree in related field

High School Diploma

Tools

Microsoft Excel

Electronic Quality Management Systems

Learning Management Systems

Job description

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 support to the Quality department in the area(s) of quality, compliance and/or regulatory affairs. This role supports the overall quality program and serves as a liaison between the Quality team and other service lines of Versiti. He/she/they partners with service lines to provide quality input on projects and everyday tasks.

Total Rewards Package

Compensation The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications. Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities

• Core Quality 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.
• Prepares charts, tables, etc. to analyze quality metrics. May communicate results and actions of quality metrics.
• 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.
• Acts a resource for compliance and quality matters.
• Specific Quality Compliance Specialist Responsibilities: Perform internal audits per the approved Internal Audit Schedule
• Perform tracking and trending of data for the quality management system elements
• Participate in the compilation of Quality Management Review
• May conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems.
• 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 Specialists, Quality Compliance.
• 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 required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Qualifications

Education

• High School Diploma Plus 4-6 years Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital in lieu of required degree
• Associate's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) Plus 2-4 years experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital in lieu of required degree
• Bachelor'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 HS Diploma required
• 1-3 years experience required in related field with associate's degree required
• 1-3 years experience required in related field with bachelor's degree desired
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital in lieu of required degree

Knowledge, Skills and Abilities

• Understands and applies the principles and practices in a recognized professional field requiring extensive academic preparation and experience required
• Determines and implements a course of action based on guidelines and may modify processes and methods as required required
• Knowledge and application of external standards and regulations required
• 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
• Possess strong attention to detail required
• Generally, requires knowledge of company policies, practices, and procedures preferred
• Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred

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
• Electronic Quality Management Systems and Learning Management Systems required