Apply on Employer Site

Guerbet · 2 months ago

In-Process Quality Engineer III

Raleigh, NC

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Guerbet is a global leader in medical imaging, dedicated to improving the diagnosis and quality of life for patients. The In-Process Quality Engineer III is responsible for ensuring compliance with SOPs and cGMP during formulation, filling, sterilization, and packaging operations, as well as monitoring production areas and addressing quality events.

Health CareMedicalPharmaceutical

Responsibilities

Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations

Perform required QA inspections; i.e Sample defect detection

Ability to participate in internal audits, as requested

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

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

Assist personnel in the generation of operations/packaging area related exceptions

Have the ability to support minor exceptions and simplified CAPAs and support phase II manufacturing investigations

Attend daily operations staff communication meetings

Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling

Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as area inspections pre/post activity

Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management

Ability to support the QA label release functions on an as needed basis

Maintain active communication with customers to facilitate continuous process improvement

Identify, initiate, and implement process improvements within the Manufacturing and Quality areas

Oversee departmental projects to ensure associated timelines are met ahead of schedule

Ability to pass visual acuity exam for production and identification of quality product purposes

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

Other duties as assigned with or without accommodation

Qualification

CGMP complianceQA inspectionsRoot cause analysisASQ inspection certificationStatistical samplingMS Office proficiencyProcess improvementVisual acuityTeam collaborationCommunication skills