Coordinator-GXP QA - Regulatory Affairs
Cincinnati Children's Hospital Medical Center

Job Info

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Job Description

At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's.

Cincinnati Children's Hospital Has Been Named:

• Consistently recognized by U.S. News & World Report as a top 10 children's hospital in the nation
• One of four Medical Centers making the list of the 2022 Glassdoor Best Places to Work
• A Top Hospital and Health System for Diversity recognized by DiversityInc
• One of the nation's most innovative companies by Fortune in March 2023
• An LGBTQ+ Healthcare Equality Top Performer in 2022 by The Human Rights Campaign (HRC)

JOB RESPONSIBILITIES

• Regulatory Knowledge & Oversight- Under the direction of more senior QA staff and within a limited and clearly defined scope, applies specific elements of federal and state law and institutional policies/procedures/guidance to ensure that all aspects of manufactured products, regulatory submissions and operational procedures are compliant with regulatory directives.
  
• Quality Assurance- Designs, oversees and implements document control activities. May conduct specific reviews of defined documents under direct supervision of more senior QA staff. Issues documents for product release. Coordinates audits, training, discussions and process improvements.
  
• Teamwork, Collaboration & Leadership/Management- Work collaboratively with diverse teams and interface effectively with internal stakeholders, as a contributing team member in support of institutional initiatives.
  
• Training & Development- Coordinates activities as needed.
  

Individual typically working under the direction of senior specialist, consultant or management personnel.

JOB QUALIFICATIONS

• High school diploma or equivalent
  
• 3+ years of work experience in a related job discipline OR equivalent combination of education and experience
  

Market Leading Benefits Including*:

• Shift Differential, Weekend Differential, and Weekend Option Pay Programs
  
• Medical coverage starting day 1 of employment. View employee benefits here.
  
• Competitive retirement plans
  
• Tuition reimbursement for continuing education
  
• Expansive employee discount programs through our many community partners
  
• Referral bonus program for current staff!
  
• Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos - Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group
  
• Physical and mental health wellness programs
  
• Relocation assistance packages available for nurses!
  

*Benefits may vary based on FTE Status and Position Type

Primary Location
Burnet Campus

Schedule
Full time

Shift
Day (United States of America)

Department
Regulatory Affairs

Employee Status
Regular

FTE
1

Weekly Hours
40

Salary Range
$21.52 - $26.23

Comprehensive job description provided upon request.

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability.

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