Project Administrator – Quality Management Systems

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

Work Type

Salary

Benefits

At Denver Health, we take care of the people who take care of our community. Our benefits are built to support your life, your family, and your future — with generous paid time off, fully paid parental leave, exceptional retirement contributions, comprehensive health coverage, and nationally recognized well-being programs. We invest in your growth through tuition assistance, career advancement pathways, and professional development — while also offering meaningful financial advantages through loan forgiveness eligibility and employer contributions. When you join Denver Health, you’re joining a mission-driven organization that invests in you.

Here is a small list of our benefit programs:

• Paid time off starting at 28 days per year, inclusive of vacation, personal/sick, and 7 Holidays
• 100% paid parental leave up to 6 weeks
• Immediate eligibility for retirement plans with employer contribution up to 9.5%
• Generous medical, dental, vision plans in addition to employer paid disability and life insurance.
• Comprehensive well-being programs including on-site employee fitness center located on Denver Health main campus and nationally recognized RESTORE Center
• Free RTD EcoPass (public transportation)
• Childcare discount programs & exclusive perks on large brands, travel, and more
• Tuition reimbursement & assistance
• Education, coaching, and professional development opportunities through the Workforce Development Center (WFDC) that support internal career growth and advancement pathways
• Professional clinical advancement program & shared governance
• Public Service Loan Forgiveness (PSLF) eligible employer+ free student loan coaching and assistance navigating the PSLF program
• National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) eligible employer