QA Lead – GMP Compliance & CAPA

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

Job summary

Amgen in Juncos, Puerto Rico is seeking a Quality Assurance Manager to oversee the QA program under minimal supervision. Responsibilities include leading investigations, site audits, and maintenance of QMS documentation to ensure cGMP compliance.

Fluency in English and Spanish is valued for cross-functional collaboration. The role emphasizes partnerships with Manufacturing, Validation, Quality Control, and Regulatory bodies, with focus on continuous improvement and risk management.

Qualifications

• Doctorate or Masters with related experience required.
• Bachelor's with 4+ years related experience.
• Associates with 8+ years related experience.
• High school/GED with 10+ years related experience.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory interaction

Documentation skills

Communication skills

Independent work

Data trending

Compliance evaluation

Amgen values

Education

Doctorate or Masters + 2 years of related experience

Bachelor + 4 years of related experience

Associates + 8 years of related experience

High school/GED + 10 years of related experience

Tools

MES

EBR

SAP

EDMQ

Trackwise

DQMS

Job description

Amgen in Juncos, Puerto Rico is seeking a Quality Assurance Manager to oversee the QA program under minimal supervision. Responsibilities include leading investigations, site audits, and maintenance of QMS documentation to ensure cGMP compliance.

Fluency in English and Spanish is valued for cross-functional collaboration. The role emphasizes partnerships with Manufacturing, Validation, Quality Control, and Regulatory bodies, with focus on continuous improvement and risk management.