Job Summary
Under minimal supervision, the primary purpose of this position is to be responsible for the administration and supervision of all RMPDS Quality Assurance activities including, but not limited to Audit Activities and Corrective Actions. Requires the ability to work independently as well as collaboratively with other internal and external team members to ensure both external client and internal customer timelines and requirements are met. Makes recommendations for cost efficiency and process improvement. Utilizes software applications and information systems to perform quality functions.
Responsibilities
1. Quality Systems Auditor Quality Auditor for internal and supplier processes. Documents findings; manages corrective actions of internal, vendor, client and regulatory authority audits Conducts assessment activities including internal quality audits and supplier assessments. Responsible for Supplier Management including maintenance of Approved Supplier List, Supplier Files and documentation as required to demonstrate compliance with regulatory requirements
2. Document Revision Assists with preparation of regulatory documents. Develops/revises QA documents, including QA Plan/Manual, procedures and others. Plans, performs, reports and approves, if required QA audits, inspection and surveillance in compliance with company QA Program Maintains document control and writes/revises procedures. Maintains control of quality records.
3. Facilitates Nonconformance Programs (Nonconformance/Planned Deviation/CAPA/Complaint) Managing nonconformance process, database and documentation Conducts investigations into nonconformities and supplier issues in accordance with CAPA procedures Plans and coordinates quality assurance activities between departments. Ensures that the Company keeps abreast with current regulatory requirements including FDA, ISO, etc. Coordinates corrective and preventive actions and verifies the implementation of solutions. Documents, evaluates and when required, investigates customer complaints. Evaluates process deviations and determine appropriate actions.
4. Helps Evaluate Training Needs Ensures employee competence and awareness, identifies training needs and make sure appropriate training is provided. May supervise work performed by QA Specialist.
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 ie.Word, Excel, Access and Powerpoint, utilizing commands and basic formulas. Must have strong hands-on leadership skills.
Computers and Technology
Effective personal computing required (spreadsheets, database, word processing) and communication skills.
Supervisory Responsibilities This position has no supervisory responsibilities.
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, Internal Audits, Corrective Action, Training and Supplier Quality Assurance.
Credentials
Must be a Certified Lead Auditor or be able to be certified within a year. Certificates, Licenses and Registration All Certifications and Licenses required for this job must be kept current as a condition of continued employment.
Location
1391 Speer Blvd, Denver CO and some remote
Shift
Days
Work Type
Full time
Pay Range
Minimum: 63,500.00
Midpoint: 79,500.00
Maximum: 95,400.00
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, high-quality academic health care system considered a model for the nation that includes a Level I Trauma Center, a 555-bed acute care medical center, Denver’s 911 emergency medical response system, 10 family health centers, 18 school-based health centers, Rocky Mountain Poison and Safety, a Public Health department, an HMO and The Denver Health Foundation.
As Colorado’s primary, and essential, safety-net institution, Denver Health is a mission-driven organization that has provided billions in uncompensated care for the uninsured. Denver Health is viewed as an Anchor Institution for the community, focusing on hiring and purchasing locally as applicable, serving as a pillar for community needs, and caring for more than 185,000 individuals and 67,000 children a year.
Located near 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. As an EOE, Denver Health 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.
