About this role
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 directly related experience.
- Bachelors + 4 years of directly related experience.
- Associates + 8 years of directly related experience.
- High school/GED + 10 years of directly related experience.
PREFERRED QUALIFICATIONS:
- Preferred candidates will have GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired. Bilingual English/Spanish communication skills are 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: 5 months for the first contract with a high possibility of extension based on performance and budget.
- Administrative Shift (weekends and overtime may also be required).
- Expected hiring date: October 2026