LIMS Specialist

Job Description

Responsibilities:

Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with Merck IT and system vendors to meet the needs of various bioanalytical singleplex and multiplex assays. 

Develop a working knowledge of existing LIMS functionality as well as the data analysis requirements & acceptance criteria for various bioanalytical methods to setup assay data flows and LIMS analysis modules.

Manage day to day LIMS activities for method qualification/validation and clinical study support including user training, troubleshooting, study setup, and management of clinical sample reconciliation and data transfers in line with regulatory data standards.

Execute computer system validations, including the development of system requirements and acceptance test scripts, followed by formal system testing.  Validation work may be conducted for either LIMS or associated laboratory computerized system. 

Operate within a regulated bioanalytical laboratory, participating as needed in regulatory audits as a LIMS subject matter expert.

Develop departmental SOPs and related computer work instructions associated with LIMS or related systems.

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