Specialist Manufacturing – Supplier Change Control

Description We are seeking an experienced Specialist Manufacturing – Supplier Change Control professional to manage supplier-related Change Control Records within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have at least 5 years of relevant professional experience, with hands-on responsibility for managing Change Control Records from initiation through closure, including supplier change notifications, impact assessments, cross-functional coordination, and required documentation updates. Responsibilities Own and manage Supplier Change Control Records from initiation through closure. Review and assess supplier change notifications related to raw materials and manufacturing components. Coordinate impact assessments with cross-functional teams, including Quality, Manufacturing, Supply Chain, and other relevant departments. Organize meetings, follow up on assigned actions, and ensure timely completion of assessments and approvals. Evaluate the potential impact of supplier changes on materials, manufacturing processes, specifications, documentation, and applicable quality systems. Coordinate required updates to affected systems, procedures, and controlled documentation. Monitor change control progress, follow up on pending activities, and ensure records are completed and closed within established timelines. Maintain accurate and compliant documentation in accordance with applicable GMP requirements. Qualifications Bachelor's degree in Science, Engineering, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related field. 5 or more years of relevant professional experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. Demonstrated hands-on experience owning and managing Change Control Records throughout the entire lifecycle, from initiation through closure. Experience coordinating impact assessments, cross-functional reviews, approvals, and documentation updates. Knowledge of GMP requirements and controlled documentation in a regulated environment. Bilingual proficiency in English and Spanish, with strong verbal and written communication skills. Strong organizational, analytical, follow-up, and project coordination skills. Must reside in Puerto Rico. Direct experience managing supplier-initiated change controls involving raw materials or manufacturing components. Experience with materials such as: Raw materials, media, and chemicals Resins Single-use components and systems Filters Device packaging Familiarity with TrackWise or other electronic Change Control Management systems. Important Role Clarification This position focuses specifically on Change Control ownership and execution. Candidates must have practical experience managing records from initiation through closure, rather than experience limited to reviewing, approving, or verifying records from a Quality Assurance perspective. The role is not primarily focused on investigations, deviations, CAPA, complaints, or on-site supplier audits. Location Requirement : Candidates must reside in Puerto Rico. Availability : Immediate consideration preferred. How to Apply Please submit your updated résumé highlighting your experience managing Change Control Records end-to-end, supplier change notifications, impact assessments, cross-functional coordination, and record closure. Job Type: Full-time Pay: $35.00 - $42.00 per hour Education: Bachelor's (Preferred) Experience: Filters: 5 years (Preferred) Resins: 5 years (Preferred) Change Control Records: 5 years (Preferred) coordinating impact assessments: 5 years (Preferred) cross-functional reviews: 5 years (Preferred) approvals, and documentation updates: 5 years (Required) GMP requirements and controlled documentation: 5 years (Preferred) Raw materials: 5 years (Preferred) manufacturing components: 5 years (Preferred) Trackwise: 5 years (Preferred) SAP: 5 years (Preferred) Device packaging: 5 years (Preferred) Work Lo…

View the full posting and apply