Sr. Specialist QA- 35713

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

Job summary

Amgen seeks a technical QA specialist to support the Quality Assurance program at the Juncos, PR site. The role involves approving validation protocols, incident triage input, and characterization and release activities for utilities and processes.

The position requires extensive QA, validation, and regulatory interaction experience, with leadership responsibilities on cross-functional teams. Long-term on-site assessment with a potential contract extension is anticipated.

Qualifications

• Doctorate, Masters, Bachelors, Associate or High School with related experience per education list.
• Directly related experience counts for each education level as listed.
• Strong knowledge of validation, CGMP, and data integrity.
• Ability to interact with regulatory agencies.
• Experience in QA leadership, change control, and procedures.

Responsibilities

• Approve process validation protocols and reports.
• Represent QA on incident triage team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on CCRB.

Skills

Project management

Cross-functional leadership

Team facilitation

Negotiation

Regulatory interaction

QA and validation

Data analysis

Process development

Documentation skills

Independent work

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

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

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