Job Description

SUMMARY:

In support of Amgen's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS:

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

EDUCATION:

• Doctorate + 2 years of directly related experience.
• Masters + 4 years of directly related experience.
• Bachelors + 6 years of directly related experience.
• Associates + 10 years of directly related experience.
• High school/GED + 12 years of directly related experience.

PREFERRED QUALIFICATIONS:

• Facilities and Utilities Commissioning and Qualification
• Computer System Validation
• Equipment validation
• Risk Assessments
• KNEAT,CDOCS, SCADA, TRACKWISE, MAXIMO
• Good Documentation Practices, Data Integrity
• Change Controls
• Standard Operation Procedure
• Syringe/Vials Inspection Process
• Documents revision and approval
• Strong knowledge in Decision Making Techniques
• Risk Management

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 processes development.
• Demonstrated 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: 11 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