Computerized Systems Manager

7 days ago

Petersburg, United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to affordable, high-quality medications.

Job Description

The Computerized System Manager for Laboratory IT will oversee the implementation, validation, and maintenance of the computerized systems supporting GxP Laboratory Operations. This role will be responsible for ensuring the laboratory systems' compliance, quality, and efficiency, and maintaining data throughout the data lifecycle.

Key Responsibilities:
  • Manage existing LIMS and CDS systems and drive the selection, installation, testing, maintenance, training, and support of additional laboratory systems.
  • Ensure the laboratory systems and data comply with regulatory requirements, industry standards, and best practices for data integrity, security, and quality.
  • Implement and monitor data integrity controls, such as user access, audit trails, backups, electronic signatures, data review, and data transfer, to ensure the laboratory data's accuracy, completeness, consistency, and availability.
  • Manage the integration, validation, and maintenance of stand-alone lab instruments and ensure their compatibility and connectivity with laboratory systems and data.
  • Perform system administration tasks for Empower, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
  • Troubleshoot and resolve any issues related to Empower, such as network, database, instrument, or software problems.
  • Coordinate with vendors to ensure the proper configuration, upgrade, backup, and recovery of the Empower system.
  • Collaborate with cross-functional stakeholders to understand laboratory needs and deliver computerized system solutions that enable analytical excellence and data integrity controls.
  • Manage the computerized system budget for Laboratory Systems, resources, and vendors, ensuring the optimal utilization and allocation of system assets and services.
  • Cross-train to provide backup support for other Site IT needs.
  • Monitor and report on the computerized system performance, risks, and issues, and implement corrective and preventive actions as needed.
  • Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies.
Requirements:
  • A bachelor's degree in computer science, engineering, or a related field with 8+ years of experience in computerized system roles in the pharmaceutical or biotechnology industry.
  • A strong knowledge of computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.
  • A solid understanding of laboratory processes, systems, and technologies, including LIMS and CDS.
  • A familiarity with stand-alone lab instruments, their functions, and their requirements, such as calibration, qualification, and data transfer.
  • Experience implementing data integrity controls.
  • Proficiency in the Empower system, its features, and its administration, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
  • Experience in troubleshooting and resolving issues related to Empower, such as network, database, instrument, or software problems.
  • Capable of working independently against deadlines in a fast-paced, dynamic environment.
  • A high level of analytical, problem-solving, and decision-making skills.
  • Excellent communication, collaboration, and leadership skills.
Preferred Qualifications:
  • Experience with MODA LIMS preferred.
  • Advanced experience in project management and change management.
  • Strong knowledge of computerized system validation.
  • Experience with ELN and implementation of paperless lab.

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