Senior PQA Analyst: GMP-Driven Quality Assurance Leader

Pinnaql; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group in Puerto Rico is seeking a Quality Assurance Senior Analyst to support TPM plants and PQA functions. You will review and approve manufacturing directions, investigations, and CAPAs, and participate in annual Product Quality Reviews.

This role requires collaboration with Regulatory, Quality, Technical Supply Chain, and TPM sites to ensure cGMP compliance and effective change management.

Qualifications

• Bachelor's degree in Engineering or Science required.
• Six years of experience in pharmaceutical operations, preferably biologics manufacturing.
• Knowledge of GMP regulations and pharmaceutical standards.
• Strong analytical skills and attention to detail.
• Ability to communicate across all levels and work extended hours.

Responsibilities

• Maintains an effective liaison with Quality, Regulatory, Technical Supply Chain and TPM sites.
• Reviews and approves manufacturing directions to the production floor.
• Ensures TPM procedures comply with cGMP policies and QA specifications.
• Participates in Trend Review Board and Global Change Review Board meetings.

Skills

Analytical skills

GMP knowledge

Regulatory knowledge

Change management

Technical writing

Cross-functional collaboration

SAP

LRMS

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Job description

Validation & Engineering Group in Puerto Rico is seeking a Quality Assurance Senior Analyst to support TPM plants and PQA functions. You will review and approve manufacturing directions, investigations, and CAPAs, and participate in annual Product Quality Reviews.

This role requires collaboration with Regulatory, Quality, Technical Supply Chain, and TPM sites to ensure cGMP compliance and effective change management.