Sr. Specialist QA- 35712

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

CIS International LLC in Juncos, PR is seeking a senior QA professional to support Amgen's Quality Assurance program. The role focuses on reviewing and approving MPs, process validation, and leading investigations to ensure product quality and regulatory compliance.

You will represent QA on incident triage, NPI teams, and site quality programs, with on-site responsibilities and potential overtime. This is a full-time, 12-month project with possible extension based on performance.

Qualifications

• Requires advanced degree with directly related experience as listed.
• Experience in commissioning and qualification, equipment validation, QRAES, Kneat, GxP documentation.
• Knowledge of Change Controls, SOPs, and Good Documentation Practices.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage and NPI teams.
• Approve Environmental Characterization reports and sanitary utility releases.
• Lead investigations and owner of site quality program procedures.
• Designee for QA manager on local CCRB.
• Coordinate with regulatory agencies as needed.

Skills

Project management

Cross functional teamwork

Leadership & negotiation

Regulatory interaction

Document control & data analysis

Independent work

Education

Doctorate + 2 years exp

Masters + 4 years exp

Bachelors + 6 years exp

Associates + 10 years exp

High school/GED + 12 years exp

Job description

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: 12months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Expected hiring date: September 2026