JT165 - SPECIALIST QA

Quality Consulting Group•Juncos, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

Bachelor’s degree in Life Sciences or Engineering
4+ years of directly related QA experience in a regulated manufacturing environment
Strong Experience in Quality System such as: Deviations (Nonconformities), CAPA, and Change Control.
Strong knowledge and hands-on experience with Key Electronic Systems: Documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES / Electronic batch record systems, and SAP.
Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
Validated experience serving as Quality Contact for complex projects involving: Packaging, inspection, commissioning, qualification, and new drug substances/products.

Responsibilities

Perform quality disposition decisions (approval/rejection) for bulk drug substances in compliance with regulatory standards.
Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
Ensure all deviations are properly identified, investigated, documented, and resolved according to procedures.
Ensure that changes that could potentially impact drug substance quality are assessed according to procedures
Verify that production records and laboratory results are complete, accurate, and compliant with established procedures.
Ensure facilities, equipment, materials, and processes meet regulatory and quality requirements.
Lead and support continuous improvement initiatives, driving operational efficiency and quality enhancements.
Collaborate cross-functionally to ensure Quality Management System (QMS) processes are properly executed.
Support and participate in internal and external audits and regulatory inspections, serving as a Quality representative when needed.
Provide quality oversight and support for New Product Introduction (NPI) activities.