Project Administrator – Quality Management Systems

Denver Health and Hospital Authority•Denver, CO

12d

About The Position

The Project Administrator is responsible, under minimal supervision, for administering RMPDS quality activities, including audit and compliance activities. 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 conducts internal and supplier audits and assessments; documents findings; manages corrective actions; maintains supplier records and approved supplier documentation; prepares and revises regulatory and quality documents; maintains document control and quality records; and coordinates nonconformance, deviation, CAPA, and complaint processes. It also supports employee competency and training, coordinates quality assurance activities across departments, and helps ensure the organization remains current with applicable regulatory requirements.

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.
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

Knowledge of compliance requirements related to cGMP, ISO, 21 CFR Part 11, or other government-related quality systems.
Certified Lead Auditor.

Responsibilities

Conduct internal and supplier process audits and assessments; document findings and manage corrective actions arising from internal, vendor, client, third-party, and regulatory authority audits.
Prepare for and conduct audit activities, which may require early or late hours with advance notice in most cases.
Manage supplier records, including the Approved Supplier List, supplier files, and documentation needed to demonstrate regulatory compliance.
Assist with preparation of regulatory documents and develop or revise quality documents, including the Quality Manual and procedures.
Plan, perform, report, and approve quality audits, inspections, and surveillance as required by the company Quality Assurance Program.
Maintain document control and quality records; write and revise procedures.
Manage the nonconformance process, database, 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.
Monitor applicable regulatory requirements, including FDA and ISO requirements.
Coordinate corrective and preventive actions and verify that solutions are implemented.
Document and evaluate customer complaints and investigate them when required; evaluate process deviations and determine appropriate actions.
Identify employee training needs and help ensure appropriate training is provided to support competence and awareness.
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.
Fully 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, plus 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 other offerings.
Tuition reimbursement and assistance.
Education, coaching, and professional development opportunities through the Workforce Development Center.
Career advancement pathways and support for internal career growth.
Professional clinical advancement program and shared governance.
Public Service Loan Forgiveness eligibility, free student loan coaching, and assistance navigating the PSLF program.
Eligibility for National Health Service Corps and Colorado Health Service Corps programs.