Biopharma QA Specialist - Compliance & Validation Leader

ProQuality Network; Juncos (PR); Hybrid; USD 70,000 - 110,000; Full time

Job summary

ProQuality Network seeks a Specialist Quality Assurance (QA) to support GMP compliance in a regulated biopharmaceutical manufacturing environment in Juncos, PR. The role emphasizes investigations, validation, environmental monitoring, and cross-functional collaboration.

The candidate will lead deviation investigations, support regulatory inspections, and ensure quality systems and procedures are followed, with a focus on product release and risk management.

Qualifications

• More than 10 years in the biopharmaceutical industry with at least 5 years QA experience.
• Regulatory inspections and audit readiness experience.
• Process validation and equipment qualification experience.
• Deviation investigations and quality approvals.

Responsibilities

• Review and approve manufacturing procedures and product master documents.
• Review and approve process validation protocols and validation reports.
• Lead deviation investigations and drive timely resolution.
• Lead internal quality audits and support regulatory inspection readiness.
• Represent QA on New Product Introduction (NPI) teams.
• Review and approve change control documentation and risk assessments.

Skills

Project management

Cross-functional leadership

Quality Assurance

Regulatory compliance

Investigations

Education

Master's +2 years

Bachelor's +4 years

Associate +8 years

HS Diploma +10 years

Job description

ProQuality Network seeks a Specialist Quality Assurance (QA) to support GMP compliance in a regulated biopharmaceutical manufacturing environment in Juncos, PR. The role emphasizes investigations, validation, environmental monitoring, and cross-functional collaboration.

The candidate will lead deviation investigations, support regulatory inspections, and ensure quality systems and procedures are followed, with a focus on product release and risk management.