Title: LIMS Specialist II
Location: West Point, PA
Start date: ASAP

Our client is looking for the following:
Responsibilities:
• Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with Company’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.

With the following credentials:
Requirements:
• 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)
• Capable of working independently under project timelines
• Strong collaborator, possessing both excellent verbal and written communication skills
• 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)


System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. 




 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.