CIS International LLC
SUMMARY
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.
FUNCTIONS
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
EDUCATION
Masters + 2 years of directly related experience.
Bachelors + 4 years of directly related experience.
Associates + 8 years of directly related experience.
PREFERRED QUALIFICATIONS
NPI, Change Control, FATs, Validation, and PPQs.
SKILLS
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
WORK METHODOLOGY
Full on site job in Juncos, PR
Full time job
Expected project duration: 5 months for the first contract, with a high possibility of extension based on performance and budget.
Administrative Shift from Monday to Friday. Weekends and overtime may also be required.
Professional services contract.
Expected hiring date: February 2026
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FUNCTIONS
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
EDUCATION
Masters + 2 years of directly related experience.
Bachelors + 4 years of directly related experience.
Associates + 8 years of directly related experience.
PREFERRED QUALIFICATIONS
NPI, Change Control, FATs, Validation, and PPQs.
SKILLS
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
WORK METHODOLOGY
Full on site job in Juncos, PR
Full time job
Expected project duration: 5 months for the first contract, with a high possibility of extension based on performance and budget.
Administrative Shift from Monday to Friday. Weekends and overtime may also be required.
Professional services contract.
Expected hiring date: February 2026
#J-18808-Ljbffr