Plant Quality Assurance Specialist

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 80,000 - 105,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, PR is seeking a Plant Quality Assurance professional responsible for reviewing cGMP processes, batch records, and QMS alignment across departments.

The role emphasizes deviation management, CAPAs, change control, and supporting internal/external audits, with bilingual English/Spanish communication and cross-functional collaboration to uphold product quality and compliance.

Qualifications

• Bachelor’s degree in Science or Engineering.
• 4 years of directly related experience.
• Excellent written and spoken English and Spanish.

Responsibilities

• Review, approve, and track cGMP processes, procedures, testing methods, and batch records.
• Lead deviations, CAPAs, and validations documentation.
• Ensure QMS alignment and cross-functional collaboration.
• Support internal/external audits and inspections.
• Champion continuous improvement and training within QA.
• Assist New Product Introduction and validation activities.

Skills

Quality Assurance

cGMP knowledge

Cross-functional collaboration

Validation knowledge

Bilingual English/Spanish

Education

Bachelor's degree in Science or Engineering

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, PR is seeking a Plant Quality Assurance professional responsible for reviewing cGMP processes, batch records, and QMS alignment across departments.

The role emphasizes deviation management, CAPAs, change control, and supporting internal/external audits, with bilingual English/Spanish communication and cross-functional collaboration to uphold product quality and compliance.