Manufacturing Engineer- (QA)
Company: Guerbet
Location: Raleigh
Posted on: May 2, 2024
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Job Description:
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:Our Manufacturing Engineer (QA) or IPQE I, 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
Guerbet requirements. Participates in containment, recovery, issue
escalation process, and corrective actions involving atypical
quality events. Supports team members to ensure all sampling is
accomplished in a timely manner and any defect related issues are
addressed. This position is a night shift, 9pm - 5am Monday through
Friday, and located at the Raleigh, NC site.YOUR 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. Perform the QA
review and approval of executed Production batch records real-time
(RTR).4. Perform QA review for completed Sterilization records and
associated documentation.5. Ability to participate in internal
audits, as requested.6. Provide 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.7. 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.8. Assist personnel in the generation of
Formulation, Filling and Packaging area related exceptions, as
needed.9. Support investigations for minor classified exceptions,
as needed.10. Team member of Facilities meetings regarding
operations Preventive Maintenance/Calibration/Work Order status and
scheduling, as designated.11. Participate as a team member during
area shutdown or maintenance projects, as needed.12. Perform weekly
walkthroughs of the operations/packaging area and communicate any
observations to associated area management.YOUR
BACKGROUND:Education required/ preferred: Associates degree in
Science/Business preferred or equivalent industry experience.
Bachelors degree in life sciences is a plus.Experience: Minimum 2
years of experience in a pharmaceutical QA/MFG environment is
desired.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 and Documentation systems (e.g., Trackwise,
Metric Stream, etc.) is preferred.The position routinely interfaces
with various personnel from Formulation, Filling, Sterilization,
Packaging, Laboratories, Facilities, Warehouse and QA.by Jobble
Keywords: Guerbet, Cary , Manufacturing Engineer- (QA), Engineering , Raleigh, North Carolina
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