QA Specialist - Vega Baja, PR
Integrated Services for Productivity & Validation, Inc, Vega Baja, Vega Baja, United States
Integrated Services For Productivity & Validation, Inc | Full time
Vega Baja, Puerto Rico | Posted on 03/11/2026
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
This role is responsible for review and audit of validation/qualification/verification activities including but not limited to manufacturing, packaging, utilities, facilities, laboratories, and systems. Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites and changes to site products including the Regulatory Impact Assessment (evaluation of market requirements and contact with Regulatory principals above site). Review and approve Operational Qualification and Performance/Process Qualification and Verification and SOP associated with these processes. In addition, this role reviews and approves analytical test methods validation/verification reports, specifications, test methods, laboratory instruments qualifications, periodic review, Risk Assessments, Commissioning Documentation, Installation Certification and Master Batch Records which include manufacturing and packaging. Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing out completed CR. Reviews proposed changes in documentation, performs the assessment of the regulatory impact of proposed changes and assures completeness of required documents before approval. Supports the PCF sponsor in the preparation of change requests by providing needed regulatory documents. Supports all activities of new R&D Products including change controls, development and validation documentation among others. Supports APR contributions process. Review documentation and CC related to shipping labels and artwork. Requirements
Must have 10 plus years of directly related experience
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This role is responsible for review and audit of validation/qualification/verification activities including but not limited to manufacturing, packaging, utilities, facilities, laboratories, and systems. Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites and changes to site products including the Regulatory Impact Assessment (evaluation of market requirements and contact with Regulatory principals above site). Review and approve Operational Qualification and Performance/Process Qualification and Verification and SOP associated with these processes. In addition, this role reviews and approves analytical test methods validation/verification reports, specifications, test methods, laboratory instruments qualifications, periodic review, Risk Assessments, Commissioning Documentation, Installation Certification and Master Batch Records which include manufacturing and packaging. Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing out completed CR. Reviews proposed changes in documentation, performs the assessment of the regulatory impact of proposed changes and assures completeness of required documents before approval. Supports the PCF sponsor in the preparation of change requests by providing needed regulatory documents. Supports all activities of new R&D Products including change controls, development and validation documentation among others. Supports APR contributions process. Review documentation and CC related to shipping labels and artwork. Requirements
Must have 10 plus years of directly related experience
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