Sr. Lab System Analyst at Rochester Regional Health in Rochester, New York

Job Description:

Description



HOW WE CARE FOR YOU:



At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients lives.

• Auto Enrolment Pension


• Comprehensive Benefits Package


• Career Advancement Opportunities including Apprenticeships


• Comprehensive Career Pathways

SUMMARY



The Sr. Laboratory Systems Analyst develops and leads enterprise-wide deployments management, configuration, support and validation of existing and new lab equipment, related software and middleware. Additionally, this position will support the lab equipment interfacing with supportive systems including: LIMS, ELN, SDMS, CDS, and other related technology. The Sr. Laboratory Systems Analyst collaborates cross functionally as a key team member in implementing and upgrading software applications for system management, compliance, and data and user integrity. Works collectively with lab operations and IT to implement, validate and maintain interfaces between the equipment, related software/middleware and ACM Data Innovation's Instrument Manager.


ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people's lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth



LOCATION: Rochester, NY



DEPARTMENT: Information Technology



SCHEDULE: Monday - Friday



ATTRIBUTES

• Bachelor's degree in a Chemistry, Lab Operations / Management, Life Science, Software Engineering or Computer Science with a minimum of 4 years of experience in related field


• OR 6 years of laboratory or laboratory system experience


• Experience with lab operations in a clinical trials environment desired


• Experience supporting lab equipment in a clinical trials, highly regulated environment desired


• Experience and knowledge with validation lab equipment and computer system desired


• Experience working with technical integration methods: HL7, FIHR, EDI, Web services, API, Database connections desired


• Experience with PMBOK and other project management methods desired


• Experience with LIMS/LIS and lab equipment implementation desired


• MLT, MLS, CLT certification desired

RESPONSIBILITIES

• 
  Laboratory Systems/Technical Support Configure process flows for development, testing, and production environments in accordance with approved protocols and scripts. Provides quality, timely and accurate lab systems analysis, design, configure Per policy, provides periodic access reviews for all lab equipment, related software and middleware. Assists in the development of system and user requirements to support identification and onboarding of new equipment in alignment with ACM computer system validation SOPs. Ensure the collection/storage of all instrument data that needs to be collected to support CT and client expectations. Performs / manages all user access to lab equipment (analyzers / other). Develop and lead enterprise-wide deployments and interfacing of lab equipment integrations utilizing instrument manager, integration with ACM LIMS systems. Where applicable, develops views, standard queries, custom reports and dashboards based on requirements. Manager of the lab equipment CMDB database for lab equipment. Supports lab equipment middleware. Manages the lab equipment/middleware database (CMDB - change management database)


• 
  Cross-Functional Collaboration Collaborates cross functionally (Lab Ops, IT, CSV) as a key team member in implementing and upgrading of software applications for system management, compliance, and data integrity. As part of a team approach (Lab Ops, IT, CSV) ensure compliant development, validation of new Instrument Interfacing through ACM's Data Innovation - Instrument Manager. Work with ACM's CSV staff to support all lab equipment and integration efforts to validate new equipment and support ongoing periodic validation of existing equipment.


• 
  Quality Guidelines Creates and maintains electronic QMS documentation including Administration and User SOP's, functional specifications/user roles and training materials. Demonstrable experience and knowledge working to the following regulatory guidelines/ standards: GAMP, FDA GxP, Gap Analysis and Quality Assurance in FDA/EMA regulated environments. Demonstrable expertise in Computer System implementation and validation in compliance with FDA GxP regulations, GAMP and ICH standards.

PHYSICAL REQUIREMENTS: L - Light Work - Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly; requires occasional walking, standing or squatting.



PAY RANGE: $70,000.00 - $100,000.00

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran Apply Now