We are recruiting for a mission-driven Project Administrator – Quality Management Systems to join our team!
We're with you for life’s journey. At Denver Health, purpose isn’t just something we believe in—it’s something we live every day, for life’s journey.
Our Values
Respect | Belonging | Accountability | Transparency
Department
RMPDS Support Svcs Admin
Job Summary
Under minimal supervision, the primary purpose of this position is to be responsible for the administration of RMPDS Quality activities including, but not limited to, Audit and Compliance Activities. 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.
Essential Functions :
· Quality Systems Auditor
• Quality Auditor for internal and supplier processes. Documents findings; manages corrective actions of internal, vendor, client, third-party, and regulatory authority audits; audit preparation/activity (may require early/late hours with advance notice in most cases).
• 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.
(40%)
· Document Revision
• Assists with preparation of regulatory documents. Develops/revises QA documents, including the Quality Manual, procedures and others.
• Plans, performs, reports and approves, if required: QA audits, inspection and surveillance in compliance with the company QA Program.
• Maintains document control and writes/revises procedures. Maintains control of quality records.
(20%)
· 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.
(20%)
· Helps Evaluate Training Needs
• Ensures employee competence and awareness, identifies training needs and makes sure appropriate training is provided.
• May review work performed by QMS Senior Support Specialist, as needed.
(20%)
Education :
· Bachelor's Degree or additional 4 years' experience in lieu of degree. Required
Work Experience :
· 4-6 years Quality Assurance experience with emphasis in Quality Control, Documentation Control, Internal Audits, Corrective Action, Training, and Supplier Quality Assurance. Required
Licenses :
· Not Required
Knowledge, Skills and Abilities :
· Compliance knowledge related to cGMP, ISO, 21 CFR Part 11, or other government related quality systems preferred.
· Experience working with quality management systems.
· Recognizes, initiates, leads and evaluates improvement efforts through initiative, judgement, tact and discretion.
· Ability to work independently and be self-directed.
· Must be familiar/proficient with Microsoft applications: Outlook, Word, Visio, PowerPoint, and Excel (applying commands and basic formulas).
· Must have strong hands-on leadership skills.
· Effective communication skills are essential.
Certified Lead Auditor - Preferred
Shift
Days (United States of America)
Work Type
Regular
Salary
$74,500.00 - $111,800.00 /…