Quality Assurance Lead - GMP, CAPA & NPI

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

Benefits offered by this job

On-site at Juncos, PR

Contract role with possible extension

Bilingual English/Spanish preferred

Job summary

Amgen in Juncos, PR is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include review/approval of MPs, process validation, incident triage, environmental characterization, and release of sanitary systems.

The ideal candidate holds a Bachelor’s degree in Science or Engineering with 4 years of related experience and demonstrates strong cross-functional collaboration, documentation control, and ability to lead audits and investigations

Qualifications

• Bachelor's degree in Science or Engineering with 4 years related experience.
• Experience in cGMP environments and quality systems is required.
• Knowledge of deviations, CAPA and change control processes.

Responsibilities

• Review and approve product MPs and process validation protocols.
• Lead site audits and investigations.
• Own site quality program procedures and QA on NPI.
• Review and approve Change Controls and CAPA records.
• Provide lot disposition and authorize lots for shipment.
• Support environmental and facilities programs.

Skills

Quality Assurance

CAPA management

Change control

Deviations handling

Risk assessment

Regulatory compliance

Cross-functional collaboration

Process validation

Education

Bachelor’s degree in Science or Engineering + 4 years of directly related experience

Tools

MES

EBR

SAP

TrackWise

DQMS

EDMQ

Job description

Amgen in Juncos, PR is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include review/approval of MPs, process validation, incident triage, environmental characterization, and release of sanitary systems.

The ideal candidate holds a Bachelor’s degree in Science or Engineering with 4 years of related experience and demonstrates strong cross-functional collaboration, documentation control, and ability to lead audits and investigations