Onsite QA Lead — Quality Assurance & Audits

CIS International; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Amgen in Juncos, PR seeks a Quality Assurance professional to support the QA program under minimal supervision. You will review and approve MPs, process validations, incident triage, environmental reports, NC investigations, CAPAs, change controls and lot dispositions, while collaborating with multiple functions on site.

The role requires a Bachelor's degree in Science or Engineering with 4 years of related experience, strong English/Spanish communication, and on-site work in Juncos, PR.

Qualifications

• Bachelor’s degree in Science or Engineering + 4 years of directly related experience.
• Experience in cGMP environments and QA systems.
• Strong documentation and record-keeping skills.

Responsibilities

• Review and approve product MPs and process validation protocols.

Skills

Quality Assurance

GxP knowledge

Regulatory interaction

QA leadership

Documentation control

Cross-functional collaboration

Education

BSc in Science or Engineering

Tools

MES

EBR

SAP

Trackwise

EDMQ

Job description

Amgen in Juncos, PR seeks a Quality Assurance professional to support the QA program under minimal supervision. You will review and approve MPs, process validations, incident triage, environmental reports, NC investigations, CAPAs, change controls and lot dispositions, while collaborating with multiple functions on site.

The role requires a Bachelor's degree in Science or Engineering with 4 years of related experience, strong English/Spanish communication, and on-site work in Juncos, PR.