Under minimal supervision, this individual will be responsible for the administration of RMPDS Quality Assurance activities including, but not limited to internal audits, internal client audits, software application validation, CAPA activity and management of ISO 9001:2015 compliant documentation. Flexibility to participate in a wide variety of projects, as well as good communication and leadership skills in a team environment are a must for this position. Experience working in a GMP and/or ISO regulated facility is a plus.. Utilizes software applications and information systems to perform quality functions.

Knowledge, Skills & Abilities: Compliance related to cGMP, ISO, or other government related quality systems preferred. Experience in quality management systems. Must be familiar with PC's and various PC-based applications i.e. Word, Excel, Access and PowerPoint, utilizing commands and basic formulas. Must have strong hands-on leadership skills

Education : Bachelor's degree and/or equivalent work experience.

Experience :Typically, five (5) to ten (10) years Quality Assurance experience with emphasis in Quality Control, Documentation Control and Data Center, Internal Audits, Corrective Action, Training, Receiving Inspection, and Supplier Quality Assurance.

Credentials : Must be a Certified Lead Auditor or be able to be certified within a year. All Certifications and Licenses required for this job must be kept current as a condition of continued employment.

Location
Rocky Mountain Poison & Drug Safety

Shift
Days

Work Type
Full time

All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made.

Denver Health is an integrated, efficient, high-quality academic health care system that is considered a model for the nation. The Denver Health system includes the Rocky Mountain Regional Level I Trauma Center, a 525-bed acute care medical center, Denver's 911 emergency medical response system, 8 family health centers, 15 school-based health centers, the Rocky Mountain Poison and Drug Center, the Denver Public Health Department, an HMO, and The Denver Health Foundation.

As Colorado's primary safety net institution, Denver Health is a mission-driven organization that has provided more than $3.3 billion in care for the uninsured in the last ten years. Denver Health is a leader in performance and quality improvements and remains financially secure, in part, due to its nationally recognized implementation of lean principles in healthcare. Denver Health is a major resource to the community, serving approximately 185,000 individuals and 67,000 children a year.

Located just south of downtown Denver, Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.

We strongly support diversity in the workforce and Denver Health is an equal opportunity employer (EOE).

"Denver Health is committed to provide equal treatment and equal employment opportunities to all applicants and employees. Denver Health is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class."

RMPDS was established in 1956 as a department within Denver Health, Rocky Mountain Poison & Drug Safety provides specialized research, education, prevention and treatment services to meet the unique and complex needs of public health, government agencies, and the pharmaceutical and consumer products industries. RMPDS employs over 200 industry professionals and provides solutions that span the lifecycle of a drug or consumer product. Our Poison Center & Health Information and Drug & Consumer Product Services groups provide 24/7/365 contact center communication, exposure management, and toxicology consulting. We offer research, analysis, and surveillance, and consulting through our Research & Consulting Services group, including our industry-leading RADARS(r) system.