Specialist QA 35269- Quality System & Validations

CIS International•Juncos, PR

1d•Onsite

About The Position

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: Doctorate or Masters + 2 years of experience. Bachelors + 4 years of experience. Associates + 8 years of experience. High school/GED + 10 years of experience. Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation. PREFERRED QUALIFICATIONS: Quality Professional with experience in Quality System and Validations. In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva. Available during weekends and holidays as requested, always available to be on site. Amgen processes experience is preferred. 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. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Amgen Values/Leadership Practices. WORK METHODOLOGY: Full on site job in Juncos, PR Full time job Expected project duration: 12 months for the first contract, with a high possibility of extension based on performance and budget. Administrative Shift (w eekends and overtime may also be required). Expected hiring date: May 2026

Requirements

Doctorate or Masters + 2 years of experience.
Bachelors + 4 years of experience.
Associates + 8 years of experience.
High school/GED + 10 years of experience.
Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.
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.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Amgen Values/Leadership Practices.

Nice To Haves

Quality Professional with experience in Quality System and Validations.
In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
Available during weekends and holidays as requested, always available to be on site.
Amgen processes experience is preferred.