CLIA Compliance Administrator

1 week ago


Newark, Delaware, United States QPS, LLC Full time
Position Overview

Are you interested in contributing to a mission-driven organization that positively impacts global health? The Clinical Laboratory Improvement Amendments (CLIA) were established to guarantee the quality of laboratory testing and ensure that test results are accurate, reliable, and timely. Laboratories may require various CLIA certificates based on the diagnostic tests they perform. QPS is accredited for high complexity testing across 49 states and specializes in custom assay development and validation, adhering to both GCP and CLIA standards to support diagnostic and clinical trial objectives.

The ideal candidate will play a vital role within the QPS team, ensuring the maintenance of our federal CMS CLIA Certificate and various state CLIA licenses and permits. This position involves supporting numerous studies and projects related to CLIA testing and compliance. A solid understanding of the fundamental requirements of CLIA testing at both federal and state levels, along with knowledge of cGCP/cGLP, is essential.

About QPS:

Since its establishment, QPS has been dedicated to assisting pharmaceutical, biotechnology, and medical device companies in their drug development initiatives. We offer a comprehensive range of services, including Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Clinical Research across various phases. Our commitment to hiring talented, compassionate, and dedicated individuals fosters a collaborative environment aimed at enhancing human health and quality of life.

Our team members engage in challenging and fulfilling work, with a culture that values diversity, innovation, accountability, teamwork, and a supportive atmosphere where performance is acknowledged and rewarded. We provide unique benefits, training, and opportunities for advancement, valuing each team member as both an employee and an individual.

Key Responsibilities

  • Manage CLIA Permits and oversee License Maintenance and Renewal.
  • Coordinate and maintain HIPAA training for both new and existing staff.
  • Assist in managing QPS' MediaLab account to fulfill NYS annual Continuing Education Units (CEU) requirements.
  • Support CLIA Testing for Clinical Trials and various QPS Projects.

Qualifications

  • A degree in a biomedical or clinical diagnostic field is preferred, with the following experience:
    1. Bachelor's Degree plus a minimum of 5 years of relevant industry experience.
    2. Associate's Degree plus a minimum of 7 years of relevant industry experience.
  • Experience in a regulated laboratory environment or in customer service/client support within the life sciences sector is preferred.
  • A background in systems and CRM database management is highly desirable.
  • Proficiency in standard Microsoft Office Suite is required.
  • Experience with database structures and usage (LIMS, Access, Quick Base) is beneficial.

Why Consider This Opportunity?

  • Excellent learning opportunities, particularly for those new to the field, with support from seasoned professionals to explore your potential and career aspirations.
  • Structured career progression paths that align with your personal goals.
  • Performance-based bonuses and merit increases as part of the total rewards strategy.
  • Comprehensive benefits package, including a company-matched 401(k) and company-sponsored life and disability insurance.
  • Engagement in internal committees focused on enhancing the experience and satisfaction of QPS employees.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. We recruit, hire, promote, and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. All job applicants and current employees are assessed solely on their abilities, experience, and job requirements.



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