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 high standards in laboratory testing, ensuring that test results are accurate, reliable, and timely. At QPS, we hold accreditation for high complexity testing across 49 states and specialize in custom assay development and validation, adhering to both Good Clinical Practice (GCP) and CLIA standards.

The ideal candidate will play a vital role within the QPS team, assisting in the maintenance of our federal CMS CLIA Certificate and various state CLIA licenses. This position will also involve supporting a range of 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 basic knowledge of cGCP and cGLP, is essential.

About QPS:

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

Our team members engage in rewarding and challenging work, supported by a culture that values diversity, innovation, accountability, teamwork, and a friendly atmosphere where achievements are recognized. 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 maintenance and renewal processes.
  • Coordinate and maintain HIPAA training for both new and existing staff.
  • Assist in the upkeep of QPS' MediaLab account to meet 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:
    1. A Bachelor's Degree and a minimum of 5 years of relevant industry experience
    2. An Associate's Degree and a minimum of 7 years of relevant industry experience
  • Experience in a regulated laboratory environment or in client support within the life sciences sector is preferred.
  • Familiarity with systems and CRM databases is highly desirable.
  • Proficiency in standard Microsoft Office applications is required.
  • Experience with database management systems (LIMS, Access, Quick Base) is beneficial.

Why Consider QPS?

  • Excellent learning opportunities, particularly for those new to the field, with seasoned professionals available to guide you in exploring your potential and career aspirations.
  • Structured career pathways that promote growth aligned with your personal goals.
  • Performance-based bonuses and merit increases as part of our comprehensive rewards strategy.
  • A robust benefits package, including a company-matched 401(k) and company-sponsored life and disability insurance.
  • A supportive work environment designed with employee needs and enjoyment in mind.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. We are committed to recruiting, hiring, promoting, and evaluating 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 applicants and employees are assessed solely based on their abilities, experience, and job requirements.



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