QC Data Reviewer M/F (28442)

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

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

WHAT WE ARE LOOKING FOR:

Responsible for conducting GMP/GDP data review of laboratory analyses and associated write-up documentation (including but not limited to wet chemistry and HPLC analysis). This position will be based onsite in Raleigh, NC. The Quality Data Reviewer will assure the analysts’ adherence to test methods, SOPs, etc. when reviewing data, and that data integrity was maintained throughout the testing process. The Quality Data Reviewer will also author laboratory investigation reports (i.e. invalidation and OOS reports). This position is full-time Monday-Friday on first shift.

Primary duties include:

Audit and approve laboratory data and reports (including wet chemistry and HPLC data)
Ensure sample data is correctly input into LIMS as required
Author lab investigations in relation to invalid or out-of-specification results (with input from analysts)
Review equipment logbooks periodically to ensure continued validated state of instrumentation
Assist in sample tracking and update sample database when samples are released from the lab

YOUR ESSENTIAL FUNCTIONS:

Ensures laboratory analyses are performed in accordance with GMP/GDP practices
Assures data integrity and ALCOA standards are applied to all laboratory data
Responsible for authoring laboratory investigations (invalidations, out-of-specifications) with input from analysts
Assist analysts in determining a root cause for aberrant results
Responsible for making sure samples released from the lab are tracked in the lab database
Responsible for reviewing equipment logbooks

YOUR BACKGROUND:

Education required/ preferred:	BS/BA degree in Life Sciences
Experience:	Seven to ten years experience in a pharmaceutical setting; previous investigation writing and auditing experience preferred
Preferred Skills/Qualifications:	Good documentation skills with eye for details
Skills/Competencies:	Ability to work in a fast paced environment
Other Skills:	Meets Baseline Skills requirements; Familiarity and skilled competency with computers, lab equipment software (Empower 3, Total Chrome, etc) and MS Office software environment

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

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.