Laboratory System Validation Specialist I
Labcorp is seeking a Laboratory System Validation Specialist I to join our team in Singapore.
Job Responsibilities:
- The candidate should possess experience with laboratory instrument operation and/or interfaces, as well as LIS/LIMS, and/or Lab Middleware, such as Data Innovations’ Instrument Manager or Siemens’ ADM
- Provides insight and guidance while leading system validations for instrument, middleware and other laboratory systems.
- Provide operational support through support of change control process for instrument, middleware, and other laboratory 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
- 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 middleware 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 Labcorp 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
Minimum Qualifications:
- Bachelor Degree in information systems, data analysis, workflow analysis.
- 3 years or more experience in a Laboratory System Analyst or Laboratory System Validations role in healthcare related industries.
- 3 years or more experience in IT/Computer validation
Preferred Qualifications:
- 3 years or more experience within a GxP and CAP/CLIA environment.
- 3 years or more experience with SDLC and/or GAMP.
Additional Job Standards:
- Knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations
- Proficiency in Chinese language as liaising with China counterparts is expected.
At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great next career step!
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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