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Date:  Jan 24, 2023
Location: 

Raleigh, US

Job Type:  Long-term/regular

 Quality Engineer II - (27927)

 

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 is an active mid-level position within the QA Compliance department.  The position does not have any direct reports, but is required to work cross functionally throughout the plant to ensure compliance levels are maintained.

 

YOUR ROLE:

  • Participant in site internal audits within the entire plant, including routine clean room behavior audits.  This includes observation identification and resolution follow-up.

  • Supportive position in the site execution of external audits from regulatory agencies (i.e Document Runner, Documentation Pre-Review etc).

  • Assist in the department completion of trending and metrics (i.e Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis).

  • Has the support role in the site supplier management program, not limited to supplier audits, supplier notifications and investigations (SCARS).

  • Support data compilation for department requirements related to site Annual Product Reviews (APRs)

  • Investigate and complete site related complaints within a timely manner.

  • Investigate and complete site related exceptions (major and minor) based on demands of the department.

  • Perform department related simplified and standard CAPAs.

  • Team member for site Kaizens or brainstorming initiatives.

  • Ability to support or perform site non-routine GMP training or awareness training sessions related to investigations or complaints.

  • Ability to perform SOP revisions as needed.

  • Ability to track the performance of assignments through to completion

 

YOUR RESPONSIBILITIES:

  • 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.

  • Support various information requests from Corporate and other departments. Interact with corporate support groups to drive global continuous improvement programs.

  • Member of Internal Audit Team.

  • Assist QA Compliance Manager with special assignments.

  • Other duties as assigned with or without accommodation.

  • Seek out and apply best quality assurance methods and practices in support of Quality objectives.

 

YOUR BACKGROUND:

Education Required/Preferred:

  • BS/BA degree in Life Sciences or Business preferred

Experience Required/Preferred:

  • Minimum 4-5  years experience in a pharmaceutical setting preferred

Preferred Skills/Qualifications/Competencies:

  • ASQ certified inspector/auditor preferred

  • Good documentation skills with eye for details

  • Ability to work in a fast paced environment

  • Meets Baseline Skills requirements; Familiarity and skilled competency with computers and MS Office software environment

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 

  • Competitive 4% 401K match + 2% profit sharing contribution 

  • Tuition reimbursement program for ongoing education