On-Site QA Specialist: Process Validation, Audits & CAPA

Conde InduServices Corp.; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Amgen seeks a QA professional to support its Quality Assurance program on-site in Juncos, Puerto Rico. You will review and approve MPs, validation protocols, change controls, and CAPA records while leading investigations and site audits.

You will own site QA procedures and collaborate with various teams to ensure regulatory compliance. Initial 5-month contract with high potential for extension based on performance and budget.

Qualifications

• Requires advanced degree and related experience in QA, validation, and GMP environments.
• Experience in change control, validation, PPQ, and CAPA is preferred.
• Strong ability to lead investigations and cross-functional teams.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits and QA investigations.
• Release of sanitary utility systems and disposition of lots.
• Own site quality program procedures and CCRB designee duties.
• Review and approve EMS/BMS alarms and change controls.
• Support automation, facilities, and environmental programs.

Skills

Project management

Organization

Cross-functional leadership

Negotiation

Regulatory interaction

Data trending

QA processes

Documentation

Communication

Education

Masters + 2 years related exp

Bachelors + 4 years related exp

Tools

MS Office

Job description

Amgen seeks a QA professional to support its Quality Assurance program on-site in Juncos, Puerto Rico. You will review and approve MPs, validation protocols, change controls, and CAPA records while leading investigations and site audits.

You will own site QA procedures and collaborate with various teams to ensure regulatory compliance. Initial 5-month contract with high potential for extension based on performance and budget.