LIMS Master Data Governance Business Analyst / Admin Position Available In Monroe, Pennsylvania

Job Description:

LIMS Master Data Governance Business Analyst / Admin Fullyonsite

• Swiftwater, PA Must have experience
• 1 years ofexperience in use and administration of a LabWare LIMS specificallycreation of product specs, sample plans and item codes.
• Strongworking knowledge of laboratory processes including cGMP’s in apharmaceutical environment.
• Experience in system testing,validation, and master data management (LIMS)
• Familiar with 21CFRpart 11 data integrity best practices in pharmaceutical environment(previous FDA experience
• must have
• Excellent written and verbalcommunications skills and the ability to lead and participate inteams
• Experience or familiarity of the Laboratory Environment(highlighted lab exp)
• Provide technical support of LIMS toQuality Control, Batch Release, Production, Stability and R Doperations (responding to tickets, helping users)

Preferred/ NiceHave Skills:

• Additional LIMS experience, building master data

Position Summary:

The Lab Information Management System [LIMS]Business Administrator is essential to Quality Operations at theSwiftwater site for supporting the maintenance and improvement ofthe LIMS system. Maintenance support will include supportingBusiness Administrators in, updating master data for new andexisting products, updating master data for new and existinganalysis, maintaining system documentation, and providing ad hocsupport to other departments. The position is expected to provideleadership to support system evolution and continuous improvement,and to support laboratory informatics needs. This role will supportthe creation and updating of master data to support the sitetransition to to a new ERP. Translation of data from existingdocuments to the electronic system for use in production and QC.

Position Responsibilities:

• Ensure site on-time implementation ofnew iSHIFT system (ERP) activities through support of master dataconfiguration and data migration and SOP revisions.
• Providetechnical support of LIMS to Quality Control, Batch Release,Production, Stability and R D operations
• Provide first leveldiagnostic of incidents and support business users, IS LIMSAdministrator and Support Center in the management and timelyresolution of technical
• Responsible for the master datamanagement process including the updating of specifications andsupporting the approval process
• Manage Global System update andchanges which may include new modules and workflow changes
• Configure and Maintain instrument interfaces to Laboratoryequipment
• Ensure that the LIMS complies with all relevantregulatory standards
• Support the business in the creation andupdating of training materials as changes to system occur
• Ensurethat the LIMS complies with all relevant regulatory standardsTechnical competencies and soft skills: Working knowledge ofaseptic processes, biology, chemistry, life sciences Knowledge ofcGMPs and regulatory requirements with Strong analytical & balanceddecision-making skills Good GMP documentation For immediateresponse, please send resume to agautam@valiantiq.

com