Senior QA Specialist: Compliance, Audits & CAPA Lead

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. supports Amgen's Quality Assurance program from its site. The role drives QA oversight for manufacturing, validation and regulatory alignment, including leading investigations and site audits.

Applicants should have advanced degrees with substantial related experience and strong cross-functional leadership, communication and data analysis skills. The position emphasizes independent work and adherence to client values.

Qualifications

• Doctorate or masters with related experience as specified.
• Bachelor's degree with years of related experience as listed.
• Experience in QA, manufacturing, validation and distribution processes.
• Ability to interact with regulatory agencies and lead audits.

Responsibilities

• Review and approve product MPs and process validation protocols/reports.
• Lead site investigations and CAPA records.
• Own site quality program procedures and QA oversight.
• Represent QA on NPI teams and coordinate cross-functional activity.
• Review risk assessments, change controls, EMS/BMS alarms and work orders.
• Support automation, facilities and environmental programs; market compliance.

Skills

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory interaction

Data analysis

Communication

Independent work

Education

Doctorate

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

Weil Group, Inc. supports Amgen's Quality Assurance program from its site. The role drives QA oversight for manufacturing, validation and regulatory alignment, including leading investigations and site audits.

Applicants should have advanced degrees with substantial related experience and strong cross-functional leadership, communication and data analysis skills. The position emphasizes independent work and adherence to client values.