Laboratory Systems Validation Specialist I

Get ready to redefine what is possible and discover your extraordinarypotential. 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 tomorrows drug development challenges creating new possibilities for our clientsand your career.

The Company - LabCorp

As one of the worlds 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

Background and 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
• Experience in audits is a plus but not required
• Fluency in English knowledge of French is a plus

Thrive personally and professionally at Labcorp

Working at Labcorp you will continue to grow in our learning-based culture so you will know how to expertly respond and adapt as the industry continues to evolve. Here you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in peoples life.

In addition Labcorp offers great benefits global experience and the opportunity to work independently within a collaborative environment.

Get to know Labcorp

At Labcorp we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities we provide insights and accelerate innovations that not only empower patients and providers but help medical biotech and pharmaceutical companies transform ideas into innovations.

Here you can join our more than 75000 employees serving clients in more than one hundred countries as we work together to make a real impact on peoples lives.

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 PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible toparticipatein the 401(k) Plan only. For more detailed information pleaseclick here.

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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