On-Site QA Lead (GMP) – 5-Month Contract

CiS International; Juncos (PR); Vor Ort; USD 78.000 - 100.000; Vollzeit

Zusammenfassung

Amgen in Juncos, PR seeks a QA professional to support Quality Assurance under minimal supervision. Responsibilities include reviewing MPs, approving validation protocols, managing incident triage, and leading site audits.

Role requires aligning with GMP/GDP and collaborating with Regulatory and Manufacturing teams. The position focuses on maintaining the site quality program, reviewing risk assessments, and guiding CAPA and change control processes.

Qualifikationen

• Doctorate or Masters with related experience
• Bachelor's degree with related experience
• Associates with related experience
• High school/GED with 10 years related experience

Aufgaben

• 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.

Kenntnisse

Project management

Cross-functional leadership

Regulatory communication

Process improvement

Ausbildung

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

Jobbeschreibung

Amgen in Juncos, PR seeks a QA professional to support Quality Assurance under minimal supervision. Responsibilities include reviewing MPs, approving validation protocols, managing incident triage, and leading site audits.

Role requires aligning with GMP/GDP and collaborating with Regulatory and Manufacturing teams. The position focuses on maintaining the site quality program, reviewing risk assessments, and guiding CAPA and change control processes.