View job listing
Apply to Sr. Specialist QA- 35712
SUMMARY:
In support of Amgen's Quality Assurance program acts as the technical specialist. Review and approve product MPs.
FUNCTIONS:
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.
- 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.
- 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