QA Specialist (PQA) - 35768 - Non Standard Shift - Juncos, PR

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 | Contract

Juncos, Puerto Rico | Posted on 09/17/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

• Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
• Actively engage in continuous improvement initiatives, programs, and projects.
• Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
• Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
• Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
• Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
• Accountable for adherence to assigned training, permitting execution of required tasks.
• Champion continuous improvement initiatives and projects.
• Provide support and oversight for New Product Introduction (NPI).
• Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
• Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
• Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
• Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
• Validated experience serving as Quality Contact for complex projects involving new products.
• Validated experience in commissioning and qualification.
• Strong organizational skills, including the ability to follow assignments through to completion.
• Enhanced skills in leading, influencing, and negotiating.
• Demonstrate the ability to interact effectively with regulatory agencies.
• Solid word processing, presentation, database, and spreadsheet application skills.
• Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
• Proven skill in working independently and effectively interacting with all levels throughout the organization.
• Advanced data trending and evaluation abilities.
• Ability to evaluate compliance issues.

Requirements

Bachelor’s degree in Science or Engineering + 4 years of directly related experience