Title: LIMS Administrator

　　Location: Iron Station, NC

　　Schedule: M-F Full Time 1st Shift

　　Type: Direct Hire

　　Responsibilities:

　　The LIMS Administrator will work within the Quality Control department supporting Chemistry, Microbiology, and Stability activities within LabVantage LIMS. The LIMS Administrator will work with the Associate Director of QC as well as cross functionally with Quality Assurance, Computer Systems Validation, IT, and Metrology on the configuration, validation and implementation of LabVantage LIMS as well as managing ongoing operations within the system. Building and validation of products, tests, and specifications within the system.

　　Authoring standard operating procedures and training guidelines for use of the system.

　　Managing user access, security settings, instrument integrations, and system configurations.

　　Performing regular system updates and patches as needed.

　　First-line support for end-user LIMS template and data entry issues providing technical support to laboratory users, troubleshooting issues, and offering guidance on LIMS usage and best practices.

　　Assist in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing of master data.

　　Develop tracking mechanisms for key performance indicators including, but not limited to, work load and cycle times for analysis, review, and release of raw materials, bulk and finished product, and stability testing.

　　Ensuring data integrity and quality within the LIMS.

　　Maintain oversight and coordination of activities in support of LIMS.

　　Review validation plans, protocols and validation summary reports associated with LabVantage LIMS.

　　Assess, determine requirements and provide approval for change controls for any requested changes to the LIMS.

　　Other duties as assigned by management.

　　Requirements:

　　Education/Training/Work Experience:

　　Minimum of Bachelor’s Degree in science, computer technology, or related field.

　　Minimum of 2-5 years of experience in the Pharmaceutical or Biotech industry

　　Minimum of 2-3 years of experience with LabVantage

　　Experience with Empower Chromatography Software

　　Nice to have experience with SQL, Groovy, or Jasper

　　Demonstrate knowledge of cGMPs, Safety, and 21 CFR regulations/requirements

　　Demonstrate knowledge of technical aspects of computer systems/software including troubleshooting and validations

　　Specialized Knowledge and Skills:

　　Project management, oral and communication, and leadership skills

　　Proficient in technical writing

　　Ability to multi-task under stress of multiple priorities

　　Detailed understanding of computer technology and systems

　　Good organizational and people skills

　　Equipment and Applications:

　　LabVantage LIMS

　　Empower Chromatography Systems

　　Giles Scientific AutoAssay

　　Bartender software

　　Other laboratory instruments such as balances, pH meters, titrators, etc.

　　Excel

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.