Senior QA Specialist - NPI, Change Control, Validation

CIS International LLC

Juncos (PR)

On-site

USD 70,000 - 100,000

Full time

3 days ago

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Job summary

Amgen is seeking a Specialist QA to support NPI, Change Control, FATs, Validation, and PPQs in a full-time, on-site role in Puerto Rico. The candidate will review and approve MP releases, validation documents, and environmental reports, while coordinating with cross-functional teams and regulatory agencies as needed.

The role emphasizes leading investigations, QA on NPI, and ownership of site quality procedures, with potential for contract extension based on performance and budget.

Qualifications

Must have advanced degree with related experience as listed.
Requires strong project management and cross-functional collaboration.
Experience interacting with regulatory agencies is a plus.
Ability to lead investigations, audits and CAPA records.

Responsibilities

Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Lead investigations and site audits.
Own site quality program procedures and QA-related change controls.
Provide lot disposition and authorize lots for shipment.

Skills

Project management

Organizational skills

Cross-functional leadership

Negotiation

Communication

Independent work

Education

Doctorate or Masters + 2 years of directly related experience

Bachelors + 4 years of directly related experience

Associates + 8 years of directly related experience

High school/GED + 10 years of directly related experience

Job description

The role emphasizes leading investigations, QA on NPI, and ownership of site quality procedures, with potential for contract extension based on performance and budget.

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