Senior PQA Analyst - TPM & Regulatory Liaison

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 52,000 - 56,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior PQA Analyst in Barceloneta, PR to oversee QA activities for TPM plants and related manufacturing processes. The role includes approving manufacturing directions, evaluating investigations, and supporting regulatory submissions with cross-functional teams.

Ideal candidates possess a BS in Engineering or Science, 5–7 years in pharmaceutical operations, and strong analytical and communication skills in English and Spanish.

Qualifications

• BS in Engineering or Science; GMP knowledge; 5-7 years pharma ops; strong analytical skills.
• Experience with GMP regulations affecting pharmaceutical products and quality systems.
• Strong communication skills across levels and teams; ability to collaborate with GMP/compliance groups.

Responsibilities

• Review and approve manufacturing directions to the production floor.
• Investigate TPM events and ensure CAPA with thorough documentation.
• Monitor process tracking, trending, and product quality performance.
• Lead annual Product Quality Review per global procedures.
• Serve as liaison with TPM sites for regulatory submissions and changes.

Skills

GMP regulations

Analytical skills

Interpersonal communications

Quality systems

Bilingual English/Spanish

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Change management

Job description

JobDiva, Inc. is seeking a Senior PQA Analyst in Barceloneta, PR to oversee QA activities for TPM plants and related manufacturing processes. The role includes approving manufacturing directions, evaluating investigations, and supporting regulatory submissions with cross-functional teams.

Ideal candidates possess a BS in Engineering or Science, 5–7 years in pharmaceutical operations, and strong analytical and communication skills in English and Spanish.