Gainesville, Georgia
Saint Louis, Missouri
Apex, North Carolina
Posted: 03-Jan-25
Location: Denver, Colorado
Internal Number: R9714
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Department
RMPDS Support Svcs AdminJob SummaryUnder minimal supervision, the primary purpose of this position is to be responsible for the administration of RMPDS Quality Assurance 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 QA 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 make sure appropriate training is provided. ? May review work performed by QA 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:
- Required
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.
- Certified Lead Auditor - preferred
Shift
Work Type
RegularSalary
$65,190.00 - $97,785.00 / yrBenefits
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, and more
Tuition reimbursement & assistance
Education & development opportunities including career pathways and coaching
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
Our Values
Respect
Belonging
Accountability
Transparency
All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made.
Denver Health is an integrated, high-quality academic health care system considered a model for the nation that includes a Level I Trauma Center, a 555-bed acute care medical center, Denver?s 911 emergency medical response system, 10 family health centers, 19 school-based health centers, Rocky Mountain Poison & Drug Safety, a Public Health Institute, an HMO and The Denver Health Foundation.
As Colorado?s primary, and essential, safety-net institution, Denver Health is a mission-driven organization that has provided billions in uncompensated care for the uninsured. Denver Health is viewed as an Anchor Institution for the community, focusing on hiring and purchasing locally as applicable, serving as a pillar for community needs, and caring for more than 185,000 individuals and 67,000 children a year.
Located near downtown Denver, Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.
We strongly support diversity in the workforce and Denver Health is an equal opportunity employer (EOE).
Denver Health values the unique ideas, talents and contributions reflective of the needs of our community. For more about our commitment to diversity visit: https://www.denverhealth.org/for-professionals/careers/diversity-and-inclusion
Applicants will be considered until the position is filled.