QA Specialist: Lead Investigations, Audits & NPI

Conde InduServices Corp.; Juncos (PR); Hybrid; USD 75,000 - 105,000; Full time

Benefits offered by this job

On-site in Juncos, PR

Job summary

Amgen is seeking a Specialist QA in Juncos, PR for a non-standard shift to support the Quality Assurance program with minimal supervision. Responsibilities include reviewing MPs, approving validation protocols and reports, leading investigations, site audits, CAPA, and change controls, and providing lot disposition for shipment.

Requires a Bachelor's in Science or Engineering with 4+ years related experience and strong English/Spanish communication.

Qualifications

• Bachelor's degree in Science or Engineering with 4+ years of related QA experience.
• Experience with cGMP/quality systems and regulatory expectations.
• Strong collaboration and cross-functional teamwork across QA, Manufacturing, and Development.

Responsibilities

• Review and approve product MPs and validation protocols.
• Lead investigations and site QA audits.
• Support CAPA, deviations, and change controls.
• Provide lot disposition and authorize shipments when compliant.

Skills

Quality Assurance

cGMP

CAPA

Validation

Audits

Regulatory interaction

Documentation

Education

Bachelor's degree in Science or Engineering + 4 years related experience

Tools

MES

EBR

SAP

EDMQ

Trackwise

Job description

Amgen is seeking a Specialist QA in Juncos, PR for a non-standard shift to support the Quality Assurance program with minimal supervision. Responsibilities include reviewing MPs, approving validation protocols and reports, leading investigations, site audits, CAPA, and change controls, and providing lot disposition for shipment.

Requires a Bachelor's in Science or Engineering with 4+ years related experience and strong English/Spanish communication.