Project Administrator – Quality Management Systems

Denver Health•Denver, CO

1d•$74,500 - $111,800

About The Position

The Project Administrator – Quality Management Systems is responsible, under minimal supervision, for administering RMPDS quality activities, including audit and compliance work. The role works independently and collaboratively with internal and external team members to meet client and internal-customer timelines and requirements, recommends cost efficiencies and process improvements, and uses software applications and information systems to perform quality functions. The position audits internal and supplier processes, documents findings, manages corrective actions, supports audit preparation and activities, and maintains supplier records and the Approved Supplier List. It also prepares and revises regulatory and quality documents, manages document and quality-record control, and plans and reports on quality audits, inspections, and surveillance. The Project Administrator manages nonconformance, planned deviation, CAPA, and complaint processes; investigates nonconformities and supplier issues; coordinates corrective and preventive actions; and ensures solutions are implemented. The role helps maintain awareness of regulatory requirements, coordinates quality activities across departments, and identifies employee training needs to support competence and awareness.

Requirements

Bachelor's degree, or an additional four years of experience in lieu of a degree.
Four to six years of Quality Assurance experience, with emphasis in Quality Control, Documentation Control, Internal Audits, Corrective Action, Training, and Supplier Quality Assurance.
Experience working with quality management systems.
Ability to work independently and be self-directed.
Familiarity and proficiency with Microsoft Outlook, Word, Visio, PowerPoint, and Excel, including commands and basic formulas.
Strong hands-on leadership skills.
Effective communication skills.

Nice To Haves

Compliance knowledge related to cGMP, ISO, 21 CFR Part 11, or other government-related quality systems.
Certified Lead Auditor.

Responsibilities

Audit internal and supplier processes; document findings and manage corrective actions arising from internal, vendor, client, third-party, and regulatory-authority audits.
Conduct internal quality audits and supplier assessments, and support audit preparation and activities.
Maintain the Approved Supplier List, supplier files, and documentation needed to demonstrate regulatory compliance.
Assist with regulatory documents and develop or revise quality assurance documents, including the Quality Manual and procedures.
Plan, perform, report, and, when required, approve quality audits, inspections, and surveillance in compliance with the company QA Program.
Maintain document control and quality records, and write or revise procedures.
Manage nonconformance processes, databases, and documentation, including planned deviations, CAPA, and complaints.
Investigate nonconformities and supplier issues in accordance with CAPA procedures.
Plan and coordinate quality assurance activities between departments.
Keep the company abreast of current regulatory requirements, including FDA and ISO requirements.
Coordinate corrective and preventive actions and verify implementation of solutions.
Document, evaluate, and when required investigate customer complaints.
Evaluate process deviations and determine appropriate actions.
Ensure employee competence and awareness, identify training needs, and ensure appropriate training is provided.
Review work performed by the QMS Senior Support Specialist as needed.
Recommend cost efficiencies and process improvements.

Benefits

Paid time off starting at 28 days per year, inclusive of vacation, personal/sick time, and seven holidays.
100% paid parental leave for up to six weeks.
Immediate eligibility for retirement plans with employer contributions up to 9.5%.
Medical, dental, and vision plans.
Employer-paid disability and life insurance.
Well-being programs, including an on-site employee fitness center and the RESTORE Center.
Free RTD EcoPass for public transportation.
Childcare discount programs and discounts on brands, travel, and more.
Tuition reimbursement and assistance.
Education, coaching, and professional development opportunities through the Workforce Development Center.
Professional clinical advancement program and shared governance.
Public Service Loan Forgiveness (PSLF) eligibility, plus free student loan coaching and assistance navigating the program.
Eligibility for National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) programs.