·Collaborating across multiple IT and Business groups to establish and ensure adherence to standardized validation best practices.
·Work with various SMEs (PM, BA, Tech Lead, Developer, Test Lead, Tester, ITQ, QA)
·Gather subject matter content and compile that information into the proper validation deliverable format (Val Plan/Report, Test Plan/Summary, Requirements, Design, Test Scripts/Executions, etc.)
·Perform Risk Assessments, and Periodic Reviews.
·Performing documentation and style editing to enhance readability for each type of document.
·Facilitating Review and Approval cycles to include updating documents with feedback and managing document control to include document timeline management and document retention.
·4+ years of validation experience working in a regulated GxP environment.
·Demonstrated understanding of software development lifecycles including but not limited to Agile and Waterfall
·Proven understanding of associated validation concepts, and knowledge of governing industry standards is required,
o21 CFR Part 11 / EMA Annex 11
oHIPAA
oOECD 17 and 22
oALCOA+
·Strong technical writing, editing, and communication skills to produce documents that are accurate, concise, focused, easy to understand, free of errors, and audience-based
·Solid verbal communication skills
·Proficiency in the use of available tools including but not limited to,
oAdobe Acrobat
oMS Office Suite applications; specifically, Word, Excel, SharePoint, and Visio
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility.
For more information about how we collect and store your personal data, please see our Privacy Statement.