Senior PQA Analyst: TPM Quality Assurance Leader

Weil Group, Inc; Barceloneta (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Weil Group, Inc. seeks a Senior Analyst, PQA Proposed to support Third Party Manufacturing plants and PQA functions. You will review investigations, supplier changes, CAPA, and Product Quality Reviews, and act as liaison with regulatory areas and TPM sites.

The role emphasizes GMP compliance, risk assessment, and coordination across Quality, Regulatory, and Supply Chain teams to ensure product quality and regulatory readiness.

Qualifications

• Bachelor’s degree in Engineering or Science and six years in pharmaceutical operations.
• Strong analytical and detail-oriented mindset with good communication skills.
• GMP regulations knowledge and quality concepts are essential.
• Experience with SAP and LRMS is highly preferred.

Responsibilities

• Maintains liaison with Quality, Regulatory, Technical, and Supply Chain teams and TPM sites.
• Ensures GMP-compliant manufacturing at TPM sites per SOPs and QA directions.
• Reviews supplier change notifications, investigations, and CAPA activities.
• Assists with Product Quality Reviews and change management plans.
• Participates in Global Change Review Board as TPM rep.
• Audits batch records and supports regulatory submissions as needed.
• Supports global projects, risk analysis, and implementation of improvements.
• Ensures investigations are thorough and well-documented.

Skills

Strong analytical skills

Attention to detail

Interpersonal skills

Effective communication across levels

Bilingual English & Spanish

Education

Bachelor’s degree in Engineering or Science

Tools

SAP

LRMS

Job description

Weil Group, Inc. seeks a Senior Analyst, PQA Proposed to support Third Party Manufacturing plants and PQA functions. You will review investigations, supplier changes, CAPA, and Product Quality Reviews, and act as liaison with regulatory areas and TPM sites.

The role emphasizes GMP compliance, risk assessment, and coordination across Quality, Regulatory, and Supply Chain teams to ensure product quality and regulatory readiness.