Sr. Specialist QA

Full time JobFull on site job in Juncos, PRAdministrative Shift

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.
SKILLS:Project management skills.Strong organizational skills, including ability to follow assignments through to completion.Initiate and lead cross functional teamsEnhanced 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.