Laboratory Systems Validation Specialist I

Labcorp • Indianapolis, IN

20h • Onsite

About The Position

Get ready to redefine what is possible and discover your extraordinary potential. Here at Labcorp, you will have the opportunity to personally advance healthcare and are effective in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you will be empowered to own your career journey with mentoring, training, and personalized development planning. Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career. The Company - LabCorp As one of the world's largest and most comprehensive drug development services companies, LabCorp has helped pharmaceutical and biotech companies develop one-third of all prescription drugs in the marketplace today. The Position We are seeking a Lab Systems Validations Specialist to perform activities related to the effective validation of laboratory instruments, middleware, and other specific systems. Responsibilities include close coordination with the Laboratory Systems Implementation Specialists, Laboratory Global Directors, Lab Project Managers, and IT shared services as well as external vendors. This position with be office based in Indianapolis, IN at our Scicor Drive location. Duties will include the following: Strategy and Business Development: The candidate should possess experience with laboratory instrument operation and/or laboratory analysis applications. Provides insight and guidance while leading system validations for instrument, software applications (particularly customized applications) and other laboratory systems. Take lead in writing and maintain records of all required system validation deliverables including, but not limited to, validation plans, requirement specifications, test plan, traceability matrix, summary reports, etc. Provide operational support through support of change control process for laboratory instrument and systems. Responsible to participate in the assessment and description of, in close collaboration with the laboratory subject matter experts (SME), the expected behavior of the systems to automate some process steps and be able to translate them into formal requirements to whomever relevant (IT, person in charge of configuring rules...). These requirements will include potential changes/set-up needs outside of the middleware such as LIS to have the expected data workflow thanks to higher level understanding of data flow across systems Provides technical consults, as needed, for both internal and external clients Leadership duties and responsibilities: Ensures the collection of system requirements through communication with stakeholders and documentation of system requirements according to specified methodologies, Owns and produces appropriate validation documentation. The ideal candidate possesses experience within a GxP and CAP/CLIA environment. Experience with SDLC and/or GAMP is a plus. Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument software platforms Responsible to lead requirement gathering efforts for middleware interface development efforts. Works with Testing Enablement and IT project managers and resources owners to coordinate resources for system test efforts Responsible for driving overall performance and delivery of on-time services Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business. Responsible for ensuring client satisfaction Performance Monitoring and Evaluation: Responsible to monitor execution of system testing according to specified metrics, identifies and resolves issues and challenges; escalates issues as needed. Accountable for the pre-QA evaluation and treatment of system test results, ensuring appropriate and complete test packages for each system effort in which he/she is involved. Responsible for timely and efficient work output within each functional area in accordance with Covance quality standards. Responsible to balance operational support assignment with at least one active project assignments. Ensures resources are sufficient to meet established performance and quality goals Ensures regulatory compliance Collaborate between the local department unit and counterparts at other sites and with other functional areas Duties and Responsibilities General: Perform duties of qualification specialist roles as needed in times of high customer demand. Coordinates the review, approval, and retention of validation documentation Provides written and verbal reports to project managers and/or GLSS leadership Responsible to execute all HR and training-related personnel tasks as defined by the company and department Provide a monthly report to the Manager Individual is responsible for maintaining his/her complete up-to-date training file. Individual is responsible for ensuring he/she is trained, and training is documented prior to performing a task. Individual is accountable for any deficiencies found in his/her training file. Support a culture of continuous improvement, quality, and productivity

Requirements

• Bachelor of Science/Engineering or higher degree in a related area of study
• Background in information systems, data analysis, workflow analysis within the pharmaceutical industry
• Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory
• 3 to 5 years’ experience in a regulated Computer System Validation (CSV), Laboratory System Analyst or Laboratory System Validations role (or similar experience).
• Experience in IT/Computer validation (to leverage important inputs on how to manage the workflow, how to avoid data integrity problems, evaluate upfront solutions with less validation effort and capture any event possibility required by a system when setting complex rules)
• Experience in requirements gathering, documentation in a regulatory environment
• Strong knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations is an added value
• Strong knowledge of lab workflow and processes
• Previous ownership in computer system validation (CSV) and/or software testing activities
• Fluency in English

Nice To Haves

• Experience with SDLC and/or GAMP is a plus.
• Experience in audits is a plus but not required
• knowledge of French is a plus

Responsibilities

• Provides insight and guidance while leading system validations for instrument, software applications (particularly customized applications) and other laboratory systems.
• Take lead in writing and maintain records of all required system validation deliverables including, but not limited to, validation plans, requirement specifications, test plan, traceability matrix, summary reports, etc.
• Provide operational support through support of change control process for laboratory instrument and systems.
• Responsible to participate in the assessment and description of, in close collaboration with the laboratory subject matter experts (SME), the expected behavior of the systems to automate some process steps and be able to translate them into formal requirements to whomever relevant (IT, person in charge of configuring rules...).
• Provides technical consults, as needed, for both internal and external clients
• Ensures the collection of system requirements through communication with stakeholders and documentation of system requirements according to specified methodologies
• Owns and produces appropriate validation documentation.
• Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument software platforms
• Responsible to lead requirement gathering efforts for middleware interface development efforts.
• Works with Testing Enablement and IT project managers and resources owners to coordinate resources for system test efforts
• Responsible for driving overall performance and delivery of on-time services
• Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
• Responsible for ensuring client satisfaction
• Responsible to monitor execution of system testing according to specified metrics, identifies and resolves issues and challenges; escalates issues as needed.
• Accountable for the pre-QA evaluation and treatment of system test results, ensuring appropriate and complete test packages for each system effort in which he/she is involved.
• Responsible for timely and efficient work output within each functional area in accordance with Covance quality standards.
• Responsible to balance operational support assignment with at least one active project assignments.
• Ensures resources are sufficient to meet established performance and quality goals
• Ensures regulatory compliance
• Collaborate between the local department unit and counterparts at other sites and with other functional areas
• Perform duties of qualification specialist roles as needed in times of high customer demand.
• Coordinates the review, approval, and retention of validation documentation
• Provides written and verbal reports to project managers and/or GLSS leadership
• Responsible to execute all HR and training-related personnel tasks as defined by the company and department
• Provide a monthly report to the Manager
• Individual is responsible for maintaining his/her complete up-to-date training file.
• Individual is responsible for ensuring he/she is trained, and training is documented prior to performing a task.
• Individual is accountable for any deficiencies found in his/her training file.
• Support a culture of continuous improvement, quality, and productivity

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level