Guerbet
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What we are looking for 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. 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.
Your Role
Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
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 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.
Department Specific/ Non-Essential Functions
Work safely in accordance with regulations, standards, and procedures and eliminate 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
Your Background
BS/BA degree in Science/Business preferred
Bachelor’s degree in life sciences preferred
Minimum 6 years experience in a pharmaceutical QA/Mfg environment
Previous experience with statistical sampling plans.
Previous experience in investigation root cause analysis and/or writing.
Ability to work in a fast paced environment.
Ability to adjust work schedule to meet operations and customer demand.
Must be able to wear appropriate personal protective to insure safe execution of job responsibilities.
Cognitive Requirements
Skilled competency with computers, MS Office software required.
Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred
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Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Guerbet
What we are looking for 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. 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.
Your Role
Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
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 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.
Department Specific/ Non-Essential Functions
Work safely in accordance with regulations, standards, and procedures and eliminate 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
Your Background
BS/BA degree in Science/Business preferred
Bachelor’s degree in life sciences preferred
Minimum 6 years experience in a pharmaceutical QA/Mfg environment
Previous experience with statistical sampling plans.
Previous experience in investigation root cause analysis and/or writing.
Ability to work in a fast paced environment.
Ability to adjust work schedule to meet operations and customer demand.
Must be able to wear appropriate personal protective to insure safe execution of job responsibilities.
Cognitive Requirements
Skilled competency with computers, MS Office software required.
Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred
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