Sr. Specialist QA- 35713

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