QA Specialist – GMP, CAPA & Continuous Improvement

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a QA-focused professional to perform on-the-floor review and approval of cGMP processes, batch records, and testing methods. You will investigate deviations, drive CAPA implementation, and support internal/external audits. The role requires strong collaboration across Quality, Manufacturing, Validation, and Engineering, with bilingual English/Spanish communication.

Qualifications

• Bachelor’s degree in Science or Engineering with at least 4 years of directly related experience.
• Experience validating GxP applications and writing validation protocols.
• Proven ability to lead, communicate in English and Spanish, and interface with regulatory agencies.

Responsibilities

• Perform on-the-floor PQA review, approval, and tracking of cGMP processes, procedures, testing methods, documents, and batch records.
• Ensure deviations, CAPAs, and validations are properly investigated and documented.
• Support audits and inspections as part of the audit/inspection management team.
• Collaborate cross-functionally to ensure QMS, Manufacturing, Process Development, Validation, and QC adhere to procedures.

Skills

Quality Assurance

cGMP

CAPA

Validation

Cross-functional

Bilingual

Education

Bachelor’s degree in Science or Engineering

Tools

SAP

Trackwise

EDMQ

DQMS

MES

IQ/OQ/PQ

Job description

Integrated Services For Productivity & Validation, Inc is seeking a QA-focused professional to perform on-the-floor review and approval of cGMP processes, batch records, and testing methods. You will investigate deviations, drive CAPA implementation, and support internal/external audits. The role requires strong collaboration across Quality, Manufacturing, Validation, and Engineering, with bilingual English/Spanish communication.