Sr. Specialist QA- 35713

Cis-International-LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen is seeking a senior QA professional to support the Quality Assurance program, acting as a technical specialist to review and approve product MPs and key QA deliverables. The role includes leading investigations, owning site quality procedures, and representing QA on NPI teams within a full on-site capacity in Juncos, PR.

The candidate will be responsible for process validation approvals, incident triage participation, and the release of sanitary utility systems, while ensuring Data

Qualifications

• Doctorate or master's degree with relevant experience.
• Bachelor's degree with progressive experience.
• Associates with long-term related experience.
• High school or GED with extensive related experience.

Responsibilities

• Approve process validation protocols and reports for manufacturing 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.

Skills

Project management

Cross-functional leadership

Documentation & data integrity

Regulatory interaction

Communication & presentation

Independent work

Process development

QA knowledge

Data trending & evaluation

Education

Doctorate + 2 years of related experience

Masters + 4 years of related experience

Bachelors + 6 years of related experience

Associates + 10 years of related experience

High school/GED + 12 years of related experience

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