Sr. Lab System Analyst

$70,000 - $100,000/Yr

Rochester Regional Health - Rochester, NY

posted 4 months ago

Full-time - Mid Level
Rochester, NY
Hospitals

About the position

The Sr. Laboratory Systems Analyst at ACM Global Laboratories plays a crucial role in the management, configuration, support, and validation of laboratory systems and equipment. This position is responsible for leading enterprise-wide deployments of lab equipment and related software, ensuring that all systems are integrated effectively with supportive technologies such as LIMS, ELN, SDMS, and CDS. The analyst will collaborate with various departments, including lab operations and IT, to implement and upgrade software applications that ensure compliance, data integrity, and user satisfaction. This role is pivotal in maintaining the interfaces between lab equipment and ACM Data Innovation's Instrument Manager, thereby enhancing operational efficiency and supporting the organization's mission to improve patient lives. In addition to technical responsibilities, the Sr. Laboratory Systems Analyst will be involved in cross-functional collaboration, working closely with teams to ensure that all lab equipment and software applications meet regulatory standards and operational requirements. The analyst will also be responsible for creating and maintaining quality management system (QMS) documentation, including standard operating procedures (SOPs) and training materials, to ensure compliance with FDA GxP regulations and other industry standards. This position offers a unique opportunity to contribute to the advancement of laboratory science within a supportive and growth-oriented environment.

Responsibilities

  • Configure process flows for development, testing, and production environments in accordance with approved protocols and scripts.
  • Provide quality, timely, and accurate lab systems analysis, design, and configuration.
  • Conduct periodic access reviews for all lab equipment, related software, and middleware as per policy.
  • Assist in the development of system and user requirements to support the onboarding of new equipment in alignment with ACM computer system validation SOPs.
  • Ensure the collection and storage of all instrument data to support clinical trials and client expectations.
  • Manage user access to lab equipment and analyzers.
  • Develop and lead enterprise-wide deployments and interfacing of lab equipment integrations utilizing instrument manager and ACM LIMS systems.
  • Create views, standard queries, custom reports, and dashboards based on requirements.
  • Manage the lab equipment CMDB database for lab equipment and support lab equipment middleware.
  • Collaborate cross-functionally with Lab Ops, IT, and CSV teams to implement and upgrade software applications for system management, compliance, and data integrity.
  • Create and maintain electronic QMS documentation, including SOPs, functional specifications, and training materials.

Requirements

  • Bachelor's degree in Chemistry, Lab Operations/Management, Life Science, Software Engineering, or Computer Science with a minimum of 4 years of experience in a related field, or 6 years of laboratory or laboratory system experience.
  • Experience with lab operations in a clinical trials environment is desired.
  • Experience supporting lab equipment in a clinical trials, highly regulated environment is desired.
  • Knowledge of validation lab equipment and computer systems is desired.
  • Experience with technical integration methods such as HL7, FIHR, EDI, Web services, API, and database connections is desired.
  • Familiarity with PMBOK and other project management methods is desired.
  • Experience with LIMS/LIS and lab equipment implementation is desired.
  • MLT, MLS, or CLT certification is desired.

Nice-to-haves

  • Experience in a clinical trials environment.
  • Knowledge of regulatory guidelines such as GAMP, FDA GxP, and ICH standards.

Benefits

  • Pension Plan
  • Retirement Plan
  • Comprehensive Benefits Package
  • Tuition Reimbursement
  • Benefits Effective Date of Hire
  • Same Day Pay through Daily Pay
  • Employee Referral Program
  • Employee Assistance Program
  • Employee Discounts
  • Paid Time Off & Holidays
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