LAB INFORMATION MGMT SYSTEMS SPECIALIST (LIMS) WEST POINT, PA Hybrid Schedule, Onsite 2 days a week. Extensive experience with Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.
B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 5+ years of industry experience, an M.S. With 3-4 years of related experience, or a Ph.D. With 1 year of related experience.
Direct experience participating in Computer System Validations.
Extensive experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.
Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMs system or through other applications (e.G., Microsoft Excel).
Experience working with vaccine bioanalytical assays, primarily those involved with immunogenicity or molecular-based assessments.
Working knowledge of data delivery standards (e.G., CDISC) and applicability to bioanalytical data.
Strong MS Excel knowledge as well as general SQL query development skills and ability to understand database relationships and structures.
Ability to develop process flow diagrams within existing tools (e.G., MS Visio).
Capable of working independently under project timelines.
Strong collaborator, possessing both excellent verbal and written communication skills.
Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with the Client' s 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.
This 11+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com
ALPHA' S REQUIREMENT #23-00896
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE