For Quality services in the Quality and Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) and Five (5) years of experience in the Quality or Manufacturing area. Experience in: Electronic Batch Record Review Quality or Manufacturing experience Documentation GMP & GDP regulations The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Administer and maintain the Electronic Batch Record (EBR) system, including user access, configuration, and system updates. Oversee the creation, review, approval, and archival of electronic batch records in compliance with regulatory requirements, Good Manufacturing Practices (GMP), and company SOPs. Identify opportunities to streamline electronic batch record processes, improve data integrity, and enhance system functionality to increase efficiency and productivity. Provide training and support to manufacturing personnel on the proper use of the EBR system, ensuring understanding of procedures and compliance with data entry requirements. Perform regular audits and reviews of electronic batch records to verify accuracy, completeness, and compliance with regulatory standards and internal quality procedures. Investigate and resolve EBR system issues, data discrepancies, and user errors, collaborating with IT and quality assurance teams as needed. Manage changes to electronic batch record templates, workflows, and configurations through the company's change control process, ensuring proper documentation and validation. Stay informed about regulatory requirements related to electronic batch records and ensure the EBR system remains compliant with evolving standards and guidelines. Participate in continuous improvement initiatives to enhance EBR system functionality, data integrity, and user experience, driving operational excellence within the manufacturing environment. Collaborate with cross-functional teams, including manufacturing, quality assurance, regulatory affairs, and IT, to support integration of the EBR system with other enterprise systems and processes. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece? Powered by JazzHR
