Labeling and Documentation Supervisor M/F (27970)

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'RE LOOKING FOR:

Our Label and Documentation Supervisor is an active supervisor position within the Quality System team, reporting directly to the Quality System Manager. The position will be required to function as a team lead, located at our Raleigh, NC site. The team lead will have the knowledge of the quality system documentation control (i.e., batch record, procedures, label and issuance of said documents). It is cross functionally role supporting production in ensuring compliance level of documents are maintained and that customer requirements are obtained by team members. This person is expected to be a SME (Subject Matter Expert) for the quality system for document control (i.e., batch record, procedures, and label)

YOUR ROLE:

The supervisor will lead the quality system documentation control and production label.
Perform administrative duties associated with overseeing team members of a department and staff. (i.e. support establish group goals)
Identify quality issues, and in conjunction with internal and external customers, recommend and implements corrective and preventative actions.
Good communication with multiple individuals, departments, contractors, vendors, auditors and strong organizational skills
Knowledge of cGMP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
Knowledge of industry documentation: labels, batch records and SOPs etc.
Issuance of Batch Records is an accurate representation of the Master Batch Records
Revision of Master Batch Records and procedure are accurate and are align within Guerbet policies and procedures.
Oversee the Standard Operating procedure program, ensure compliance within our procedures in the triennial review, revision, and issuance of documents.
Liaison with Regulatory parties within Guerbet (Domestic and International) on Label, inserts and carton art initiations or revisions.
Coordinate internal document routing for revisions in compliance with Guerbet policies and procedures
Oversee the Inspect of incoming label materials for accuracy against current revisions and review new artwork. That codes labeling and packaging lines with all labeling materials criteria are met. That packaging reports and reconcile label accountability is maintained as accurate label inventory.

YOUR BACKGROUND:

BS/BA degree in Life Sciences or Business is preferred
Minimum 5 years' experience in a pharma setting highly preferred
ASQ certified inspector auditor preferred
Pharmaceutical knowledge of production, Chemistry, and Microbiology is preferred
Knowledge of cGMP, GLP, FDA, EU, ICH and 21 CFR 11 regulations, guidelines, and policies and procedures
Strong technical writing skills; Competent with MS Office software
Previous ecperience in people management
Proven analytical aptitude and ability to utlize critical thinking on key concepts

YOUR WORKING CONDITIONS:

First shift office environment. Overtime or weekend work is dependent upon site demands. Expect 10-20% travel to assist in supplier management program. Visits to laboratory, manufacturing, warehouse, and other plant areas are required.

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.