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Date:  Jan 25, 2023
Location: 

Raleigh, US

Job Type:  Long-term/regular

 QA Support Administrator - (27792)

 

At Guerbet, we build lasting relationships so that we enable people to live better. 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.  

 

Achieve, Cooperate, Care, and Innovate are the values ​​that we share and practice

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.

 

WHAT WE'RE LOOKING FOR:

This position will provide administrative support to the Guerbet Quality Assurance group and help managers and staff deliver business success in line with best practices. Additionally, this role will provide a full scanning and photocopying service of GMP documentation as part of the Quality Assurance Team.

 

YOUR ROLE:

  • To provide an efficient administration service to the Quality Department. This may include such tasks as scanning, reconciliation, filing, archiving and retrieval.

  • To ensure all administration databases and tracking tools are up to date and correct.

  • Support Regulatory and external request management for documents and other deliverables

  • Ensure all electronic filing and manual filing systems are kept up to date.

  • Ensure adequate scanning, labelling and managing of electronic files to meet GMP requirements  

  • Assist in the processing of documentation that requires hard copy routing for approvals and mailing.

  • Assist in submitting questionnaires and documentation requests/replies via email (or by uploading to web-based folders), as needed

  • Any other duties commensurate with this role.

 

YOUR DEPARTMENT:

  • Support the site QA groups, as needed.

  • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. 

  • Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. 

  • Report all safety and/or environmental incidents to management immediately.

  • Other duties as assigned with or without accommodation.

 

YOUR ORGANIZATIONAL SCOPE:

  • Reports to the Quality Operations Manager.

  • Frequent communication with Production Manager, Quality staff and Team Leaders.

  • Work may be reviewed by internal auditors, through random checks, and may also be reviewed by external auditors.

  • Works on plant teams that investigate complex production issues.

 

YOUR BACKGROUND:

Education Required/Preferred:

  • HS Diploma required

  • Associate Degree is preferred.  

Experience Required/Preferred:

  • Pharmaceutical Industry – 1-3 years preferred

  • Auditing and reviewing documentation

  • Working knowledge of Microsoft Office

Preferred Skills/Qualifications/Competencies:

  • Experience using Quality data management systems

  • Organized and detail focused

  • Able to communicate and work across multiple functions (Corporate, Quality, Manufacturing).

  • Scanning and Photocopying experience. 

  • IT literate, Microsoft packages. 

  • Customer service focused

  • Ability to work independently; planning, organization, leadership, change capability

  • Ability to utilize Microsoft office, Word, Excel, etc. or equivalent.

EQUAL EMPLOYMENT OPPORTUNITY
Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.
 
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.
 
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.
 
WHY GUERBET? 

  • 4 weeks of PTO 
  • Exempt-employee benefits start on start date, non-exempt benefits start a month after hire 
  • Tuition reimbursement program for ongoing education