QA Specialist Lead: Validation, Audits & CAPA

Weil Group, Inc; Puerto Rico; On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen seeks a Quality Assurance professional to support QA program under minimal supervision, performing multiple duties across manufacturing and distribution. The role requires strong collaboration with regulatory agencies and cross-functional teams to ensure compliance and product quality.

Responsibilities include reviewing MPs, approving validation protocols, leading investigations, site audits, and maintaining site quality procedures.

Qualifications

• Doctorate or
• Masters with related experience
• Bachelors with related experience
• Associates with related experience
• High school/GED with related experience

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Release of sanitary utility systems and NC investigations.
• Own site quality program procedures and change controls.
• Represent QA on NPI team and support facilities/environmental programs.

Skills

Project management

Cross-functional leadership

Regulatory interaction

Data analysis

Communication skills

Independent work

Audit leadership

Education

Doctorate

Masters + 2 years related experience

Bachelors + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Job description

Amgen seeks a Quality Assurance professional to support QA program under minimal supervision, performing multiple duties across manufacturing and distribution. The role requires strong collaboration with regulatory agencies and cross-functional teams to ensure compliance and product quality.

Responsibilities include reviewing MPs, approving validation protocols, leading investigations, site audits, and maintaining site quality procedures.