Job Information
Denver Health Project Administrator, Quality Assurance in Denver, Colorado
We are recruiting for a motivated Project Administrator, Quality Assurance to join our team!
We are here for life's journey. Where is your life journey taking you?
Being the heartbeat of Denver means our heart reflects something bigger than ourselves, something that connects us all:
Humanity in action, Triumph in hardship, Transformation in health.
DepartmentRMPDS Support Svcs Admin
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.
Essential Functions:
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. (40%) 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. (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 make sure appropriate training is provided. * May review work performed by QA Specialist, as needed. (20%) Education:
Bachelor's Degree Required Work Experience:
4-6 years 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. R Licenses:
Knowledge, Skills and 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 i.e. Word, Excel, Access and PowerPoint, utilizing commands and basic formulas. Must have strong hands-on leadership skills. Effective personal computing required (spreadsheet, database, word processing) and communication skills.
ShiftDays (United States of America)
Work TypeRegular
Salary$65,190.00 - $97,785.00 / yr
Benefits
Outstanding benefits including up to 27 paid days off per year, immediate retirement plan employer contribution up to 9.5%, and generous medical plans
Free RTD EcoPass (public transportation)
On-site employee fitness center and wellness classes
Childcare discount programs & exclusive perks on large brands, travel,... For full info follow application link.