Senior PQA Analyst, TPM Quality & Compliance

Creative Solutions Services, LLC; Barceloneta (PR); On-site; USD 52,000 - 57,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Analyst, PQA in Barceloneta, PR, onsite to support TPM plants and PQA functions with investigations, CAPA, and regulatory submissions.

The role involves reviewing investigations, approving manufacturing directions, and performing annual Product Quality Reviews, requiring strong GMP knowledge and cross-functional communication across QA, Regulatory, and Supply Chain.

Qualifications

• Bachelor’s degree in Engineering or Science.
• At least six years of pharmaceutical operations experience.
• Knowledge of GMP regulations and pharmaceutical quality standards.
• Strong analytical skills and attention to detail.
• Experience with SAP and LRMS preferred.
• Ability to communicate across departments and cultures.

Responsibilities

• Maintains liaison with QA, Regulatory, Technical, and Supply Chain teams and TPM sites.
• Ensures TPM production meets cGMP standards and local procedures.
• Reviews and approves manufacturing directions to the floor.
• Supports global projects and risk analysis within PQA.
• Performs annual Product Quality Reviews.
• Participates in Trend Review Board and GCRB meetings.
• Develops change management plans for TPM plant changes.

Skills

Analytical skills

GMP knowledge

Effective communication

Change management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or Science

Tools

SAP

LRMS

Job description

Creative Solutions Services, LLC seeks a Senior Analyst, PQA in Barceloneta, PR, onsite to support TPM plants and PQA functions with investigations, CAPA, and regulatory submissions.

The role involves reviewing investigations, approving manufacturing directions, and performing annual Product Quality Reviews, requiring strong GMP knowledge and cross-functional communication across QA, Regulatory, and Supply Chain.