QA Lead — GMP Compliance & Investigations

Cis-International-LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen in Juncos, PR is seeking a QA professional to support the Quality Assurance program under minimal supervision. The role includes reviewing and approving MPs, change controls, CAPA records, investigations, site audits, and maintaining site QA procedures, with full on-site duties and the possibility of extension based on performance and budget.

As part of the team, you will interact with regulatory agencies, support environmental and facilities programs, and coordinate with Manufacturing,

Qualifications

• GMP manufacturing QA experience, including review/approval of change controls, deviations, CAPAs, protocols, reports and procedures.
• Experience supporting packaging/inspection operations; strong GDP knowledge and electronic quality systems.
• Bilingual English/Spanish communication skills preferred.

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 skills

Manufacturing knowledge

QA processes

Regulatory interaction

Documentation skills

Communication skills

Independent work

Data trending

Compliance evaluation

Amgen values

Education

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

Job description

Amgen in Juncos, PR is seeking a QA professional to support the Quality Assurance program under minimal supervision. The role includes reviewing and approving MPs, change controls, CAPA records, investigations, site audits, and maintaining site QA procedures, with full on-site duties and the possibility of extension based on performance and budget.

As part of the team, you will interact with regulatory agencies, support environmental and facilities programs, and coordinate with Manufacturing,