Sr. Specialist QA- 35712

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:

• The candidate should have experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP's etc.

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: 12 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: September 2026