🌎
This job posting isn't available in all website languages

Settings

📁
Social Sciences Research
💼
Health Solutions
📅
180V5 Requisition #
Apply for Job
Share this Job
Sign Up for Job Alerts

RTI Health Solutions is currently seeking to fill the position of a GCP Quality Auditor within the Office of Quality Assurance (OQA).

 

In this role, you will report directly to the Quality Assurance Manager, Office of Quality Assurance.  You will have strong experience in Good Clinical Practice (GCP), project and process audit and validated system development lifecycle (SDLC),  along with subcontractor auditing experience is required.  Additionally, you need to be a self-starter and  to be open to working as a part of a dynamic team and expected to travel up to 10% of your time.

 

Responsibilities:

  • Conducts internal audits
  • Provides project support as needed and reviews project-related documents
  • Tracks and manages internal and external corrective and preventive actions
  • Maintains audit-related documents
  • Recognizes the need for, organizes, and conducts training programs
  • Keeps current on regulations and guidance
  • Evaluates compliance with RTI, RTI-HS, and applicable regulations, project policies and procedures
  • Reviews and writes standard operating procedures and QA policies, procedures and related documents
  • Writes audit plans and audit reports
  • Conducts audits and inspections of GCP and non-regulated documentation
  • Track and review proposals
  • Review and audit validated systems

 

 

Qualifications:

  • Bachelor’s degree in a scientific discipline
  • Minimum 5 years of experience in QA related activities including SOP development,
  • Experience with GCP audits and inspections
  • Regulatory Affairs Certification or Quality Auditor Certification desirable
  • Knowledge of and experience with FDA and ICH GCP
  • Demonstrated organizational and communication skills, both verbal and written
  • Ability to work both independently and as part of a team
  • Proficiency in MS Office applications
  • Ability to multi-task and adjust to changing work priorities
  • Certification in clinical research, regulatory affairs or auditing
  • Ability  to travel to perform subcontractor and site assessments
  • Understanding of validated System Development Lifecycle (SDLC) is preferred
#LI-BM1

 

Physical and mental demands of this role include those that must be met by an employee to successfully perform the essential functions of this job, as outlined above.  Examples include:  remaining in a stationary position for long periods of time; operating a computer and other office machinery; thinking, learning, and concentrating effectively and frequently communicating with other people, both within RTI and outside of RTI; frequently moving about inside and travel between offices and laboratories; frequently conducting laboratory site inspections (if applicable), ability to handle the stress associated in meeting frequent, multiple and tight deadlines, ability to work in excess of 40 hours per week as workload and deadlines may require, consistent demonstration of mental stability and ability to have regular, reliable and predictable attendance.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job, per RTI procedure 4.2.1. 


RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.
 
For USA Job Postings Only: RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found at https://www.rti.org/jobs.
 
For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.
 
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.

Previous Job Searches

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

SSES SCSS

Durham, North Carolina, United States, RTI Headquarters (RTP Area)

📁 Social Sciences Research

Requisition #: 19004

SSES SPHERE

Durham, North Carolina, United States, RTI Headquarters (RTP Area)

📁 Social Sciences Research

Requisition #: 180S2

SSES SPHERE

Durham, North Carolina, United States, RTI Headquarters (RTP Area)

📁 Social Sciences Research

Requisition #: 180LD

Connect

To learn more about our research and consulting services, please call us at:

  • US: +1.800.262.3011
  • Spain: +34.93.241.7766
  • UK: +44(0)161.447.6000
  • Contact us