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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

In Proces Quality Engineer (IPQE) I - 2nd Shift

Description

SUMMARY OF POSITION:

The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points.  Monitors the production/packaging areas for compliance.  Inspects product samples to ensure compliance to Covidien requirements.  Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events.  Writes OOS and minor investigations.  Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed.  Supports site and departmental initiatives. 

 

ESSENTIAL FUNCTIONS:

  1. Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
  2. Perform required QA inspections; i.e Sample defect detection
  3. Ability to participate in internal audits, as requested.
  4. Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.
  5. Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
  6. Assist personnel in the generation of operations/packaging area related exceptions
  7. Have the ability to support minor exceptions
  8. Attend daily operations staff communication meetings
  9. Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling
  10. Team member during area shutdown or maintenance projects as needed.  Assisting in punch list generation & verification, as well as, area inspections pre/post activity.
  11. Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management. 
  12. Ability to support the QA label release functions on an as needed basis

Required Skills & Background

MINIMUM REQUIREMENTS:

Education required/ preferred:

Associates degree in Science/Business preferred

Bachelor’s degree in life sciences preferred

 

Experience:

Minimum 4 years experience in a pharmaceutical QA/Mfg environment.  

 

Preferred Skills/Qualifications:

ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred); previous experience in investigation root cause analysis and/or writing (preferred)

 

Skills/Competencies:

Ability to work in fast paced environment; Ability to adjust work schedule to meet operations and customer demand; Must be able to wear appropriate personal protective equipment to insure safe execution of job responsibilities.

Other Skills:

Skilled competency with computers, MS Office software required.  Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred

 

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

 

The position routinely interfaces with various personnel from Formulation, Filling, Sterilization, Packaging, Laboratories, Facilities and QA.

 

 

WORKING CONDITIONS:

 

Pharmaceutical production and packaging areas.  Personnel must have ability to stand on their feet for prolong period of time while performing operations support tasks, but can also experience a typical office environment throughout the work hours.