Senior Quality Assurance Analyst - TPM & Regulatory

Pinnaql; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company is seeking a Senior PQA Analyst to support TPM plants and PQA functions, reviewing investigations, CAPAs, and changes. The role emphasizes GMP compliance, regulatory liaison, and product quality oversight across sites.

The ideal candidate has a strong background in pharmaceutical operations with 6+ years of experience, excellent analytical skills, and proficiency in QA systems like SAP and LRMS.

Qualifications

• Bachelor or higher in engineering or science.
• Six years in pharmaceutical operations, preferably biologics.
• Knowledge of GMP regulations and practices for pharma.
• Strong analytical skills with attention to detail.
• Experience with change control and investigations.

Responsibilities

• Support day-to-day QA activities for TPM plants and PQA.
• Review manufacturing directions, lab, and raw material investigations.
• Assess product impact, CAPA, and change approvals as applicable.
• Participate in annual Product Quality Reviews and trend boards.
• Coordinate with regulatory areas and TPM sites for submissions.

Skills

Analytical skills

Attention to detail

Technical writing

Communication across levels

SAP experience

LRMS experience

GMP knowledge

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Job description

Validation & Engineering Group Inc V&EG a Pinnaql company is seeking a Senior PQA Analyst to support TPM plants and PQA functions, reviewing investigations, CAPAs, and changes. The role emphasizes GMP compliance, regulatory liaison, and product quality oversight across sites.

The ideal candidate has a strong background in pharmaceutical operations with 6+ years of experience, excellent analytical skills, and proficiency in QA systems like SAP and LRMS.