Come join our team as a FULL TIME Quality Assurance Coordinator II

 

National Blood Testing Partners offers the following benefits on your FIRST day of employment:

  • 401(k)
  • 401(k) matching
  • Health insurance
  • Dental Insurance
  • Vision insurance
  • Paid time off (6 paid holidays per year)

Primary Purpose(S)

The QA II role serves as a critical contributor to the quality assurance function by independently managing and executing QA processes with minimal supervision. This mid-level position ensures compliance with regulatory standards through detailed reviews, internal audits, and preparation for external inspections. The QA II leads investigations and drives corrective and preventive actions (CAPAs), while also mentoring junior QA staff and laboratory personnel. With a strong understanding of regulatory requirements, the QA II maintains oversight of equipment calibration and validation, authors and enforces SOPs, and delivers QA summaries and trend analyses to support continuous improvement and operational excellence.

Qualifications:

Knowledge/Required:

  • Work Shifts: Some flexibility in the hours required to work may be required. Scheduling may be fixed or rotating based on business needs. 
  • Work shifts may include weekends, holidays, days, evenings, and nights. Employee is expected to be available after hours to meet operational needs.
  • Proficient computer skills and experience with computer programs such as MS Office (Word, Excel, Outlook, and PowerPoint)
  • Work in a variety of physical environments
  • Ability to work independently and handle multiple assignments concurrently
  • Ability to effectively participate in a stress-filled and time-critical team environment
  • Ability to train coworkers to perform a task
  • Work with confidential records and maintain confidentiality of these materials
  • Fill out and maintain records in accordance with compliance and regulatory standards
  • Analyze, think critically, and make decisions consistent with SOP and regulatory standards
  • Knowledge of state and federal laws, rules, regulations and voluntary accrediting standards related to the operation of clinical laboratories and blood banks
  • Scientific and technical knowledge from current sources, such as the AABB and EU standards and relevant guidance’s related to FDA, CMS, and CLIA, both state and federal
  • Demonstrate the necessary critical thinking and problem resolution skills
  • Root Cause Analysis: demonstrate the ability to identify the underlying causes of issues rather than just addressing symptoms
  • Analytical Thinking: demonstrate an ability to analyze data and trends to make informed decisions
  • Creative Problem Solving- demonstrate the ability to develop innovative solutions to complex problems
  • Communication- demonstrate the ability to effectively collaborate with various teams and stakeholders clearly and effectively through written reports, presentations, verbal and written.
    • Documentation and Reporting: demonstrate detailed and organized documentation and reporting
  • Mentorship and Leadership- provides guidance on best practices. Leads small teams or projects ensuring adherence to quality standards and timelines

Education: Four-year college degree: Required

Field of Study: Bachelor’s degree in chemical or biological science or Medical Laboratory Technology (ASCP) required.

Professional certification Desired: Medical Technologist, Medical Laboratory Technician, or ASQ Certification preferred

Related Experience: 2+ years’ experience in a QA, testing, or related field for Coordinator Level II role

Duties and Responsibilities

  • Coordinate compliance issues with laboratory operations and address with Quality and Lab management
  • Review/approve of non-conformance records within Perfeqta. Monitor and ensure all non-conforming events are resolved within required timeframes
  • Identify trends, non-conformances, and areas for improvement and provide guidance on best practices
  • Assist in managing the document control system, ensuring SOPs and forms are accurate, accessible, and current
  • Participate in incident reporting, CAPA tracking, and follow-up on quality improvement action items
  • Performs data entry and data analytics to support internal and external quality initiatives
  • Acts as a resource with regulatory agencies and makes recommendations for compliance, and prepares mandatory requirements as required.
  • Archive organizational documents within Medialab with management approval
  • Ensure that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented
  • Conduct periodic reviews and audits of the facility’s safety protocols to ensure alignment with regulatory standards (e.g., OSHA, EPA) and internal quality systems
  • Conduct Safety Coordinator Meetings and support Site Safety program management
  • Train and mentor QA I staff
  • Perform other duties as assigned to support laboratory quality and operational excellence.

Other Relevant Information:

You will be required to comply with governmental regulations and strictly observe privacy and security related policies, procedures, and practices to preserve the integrity and confidentiality of medical and other sensitive information pertaining to donors, patients, research subjects, and staff.

You will be required to enter areas where other individuals work with human blood; potential may exist for unanticipated exposure to bloodborne pathogens by splash or spill. 

Final offers of employment are contingent upon the successful completion of a background check, which may include verification of employment history, criminal background check, and where applicable to the position, a credit check and/or review of driving records.

We are not able to provide relocation or sponsorship for this position.  

National Blood Testing Partners is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability.