Supports quality computerized systems for QC/QA Department including Laboratories Information Management System, Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and standalone computers. Responsible for monitoring and improving quality computerized systems performance by identifying, developing and implementing initiatives to enhance system administration, data integrity compliance, CSV activities, and system's incidents resolution. Support of Company's manufacturing facility to ensure that cGMP's related IT Quality Systems are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS's business goals. Must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices as applicable. Responsibilities: 1. Support the Quality computerized systems for QC/QA Department including Laboratories Information Management System, Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and standalone computers. 2. Act as the Quality Computerized Systems SME for the site, support internal and external regulatory audits, and assure all systems are in compliance with Federal, State and Corporate Regulations supporting BMS's business goals. 3. Manages the administration of QC/QA computerized systems including user accounts configuration and maintenance, CSV documentation, system periodic review, audit trail review, computerized systems incidents evaluations and investigations, standard operating procedures for administration tasks, addition/modification of printers, execution of backup/restore/achieve, and database optimization and analysis 4. Manages the administration of Enterprise IT Support Systems (Trackwise, DCA, LIMS, Empower, etc.) at the site and assure all standard operating procedures, CSV support, investigations and troubleshooting activities are performed in compliance with site and corporate procedures, supporting BMS's business goals. 5. Support data integrity assessments activities for new and existing quality computerized systems and assure all risks are mitigated prior to system release. Provide recommendation to remediate or mitigate findings, implement and validate modifications and assure the systems are maintained in compliance with regulatory requirements 6. Support computerized systems data mappings development and/or revision to assure these are maintained in alignment with site operations and in compliance with regulatory requirements. 7. Responsible for the development, execution, and/or review of CSV documentation for quality systems and the execution of change controls as needed by QC/QA Department. 8. Performs project management functions for the execution, implementation, commissioning and validation of new and/or existing quality systems, including Enterprise solutions. 9. Coordinates and executes the installation, maintenance, qualification, and validation of upgrades for existing quality systems and Enterprise solutions supporting QC/QA Departments. 10. Fosters creative problem solving and provides technical guidance on computerized systems situations to Quality staff. 11. Assures timely closure of incidents, investigations, audit observations, CAPAs and/or change control for quality computerized systems. 12. Coordinate with suppliers of hardware/software and services for quality computerized systems problem resolution. 13. Provides technical advice on the selection of equipment and system software for data acquisition and archival and other quality related systems. Position Requirements: Bachelor Degree in Science (Chemistry, Biology or Engineering). Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must. Experience computerized system validations methodologies, 21 CFR Part 11, and Data Integrity regulations. Minimum of Six (6) years of computerized system administration within pharmaceutical manufacturing operations with proven skills in management and implementation of computerized system validation projects. Proven experience supporting laboratory and quality systems Proven skills in project management. Ability to impact and influence people/areas within the company to deliver superior business results. Excellent communication skills (oral, written and reading) in Spanish and English. SDL2017
