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Date:  Jan 20, 2023
Location: 

Raleigh, US

Job Type:  Long-term/regular

  Quality Release Supervisor - (27885)

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: 

At the Guerbet Raleigh Imaging manufacturing facility, the Quality Release Supervisor is responsible for managing the personnel and processes associated with developing, establishing and sustaining the site’s Quality Systems. This individual will manage teams supporting final batch release and incoming inspection/release activities. This position is required to work cross functionally and communicate effectively with Senior Leadership, Filling, Packaging, Labeling, Chemistry, and Microbiology departments to help assure timely lot releases.  Provide quality disposition of product using data collected during the release process. This person is expected to be a SME (Subject Matter Expert) for the site for reviewing Finished Goods documentation, incoming documentation and release as appropriate. This position will be located onsite in Raleigh, NC.

 

YOUR ROLE:

  • Responsible for supervising final audit and review activities of product documentation for Finished Goods, Returned Goods, and Incoming Goods to conform to plant procedures and industry practices.

  • Monitor KPIs and report to senior leadership on frequent basis and as requested.

  • Track and trend compliance issues and provide feedback to area management.

  • Perform product disposition and control functions in BPCS.  Trained as super user in BPCS to resolve issues as needed for Finished Goods releases.

  • Working knowledge of function testing and assure timely completion of same.

  • Compete verification documents for European markets, compile all documentation required for European production.

  • Monitor and coordinate completion of lot related events (ie documentation errors and investigations) to ensure lot release in accordance with the release schedule. Maintain databases to report FTR, Function Testing for the Annual Product Reviews (APRs), product improvement.

  • Provide technical support and training for Q&R and plant personnel.

  • 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.

 

YOUR BACKGROUND: 

Education Required/Preferred: 

  • BS degree in Science Field preferred.

Experience Required/Preferred: 

  • Pharmaceutical minimum 5 years
  • Auditing and reviewing documentation

  • Working knowledge of Microsoft Office

Preferred Skills/Qualifications/Competencies: 

  • ASQ Certified Auditor; problem solving, decision making and supervisory skills

  • Statistical analysis skills: strong communication skills and attention to detail; ability to plan, schedule and arrange work activities as appropriate

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

 

YOUR ORGANIZATIONAL RELATIONSHIPS/SCOPE:

  • Reports to Site Quality Manager.
  • Frequent communication with Senior Leadership Team, Production Superintendents, Q&R staff, and Team Leaders.

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

  • Works on plant teams that investigate complex production issues.

 

WORKING CONDITIONS:

  • Must be flexible with schedule to ensure that all essential functions for the department are met on a timely basis.
  • Visual demands to accurately review documentation.

  • Must be able to perform essential functions in multi-level, light industrial operation.

  • Must have ability to climb a multi-step ladder.

  • Normal office environment – with occasional time spent in the Warehouse.

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