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Sr. Specialist QA- 35713

  • Juncos, Puerto Rico
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