LIMS Specialist

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a highly-motivated individual to join us as a LIMS Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. This position is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.

The Laboratory Information Management System Specialist is responsible for configuration and ongoing maintenance of the LIMS system. This positon is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The LIMS Specialist works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.

Responsibilities

  • Update specifications, analyses and other static data within the Laboratory Information Management System (LIMS), as needed.
  • Provide timely response to user needs to include managing user accounts, troubleshooting applications, programming new report templates, and maintaining change records in accordance with version control procedures.
  • Provide LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, and Manufacturing staff
  • Develop, implement, and maintain Standard Operating Procedures and Work Instructions for the LIMS.
  • Develop and maintain reports in System using reporting tools both internal and external to the System.
  • Evaluate data generated and/or stored within the System to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
  • Responsibilities may include collaborating with the LIMS users and IT department to ensure new functionality meets user requirements, writing acceptance test scripts for new LIMS functionality and participating in the validation of new software releases.
  • Revise or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation.
  • Performs other related duties as assigned.

Minimum Education Requirements

  • B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands-on laboratory experience preferred)

Qualifications

  • At least 5 years of experience with the use of Labware LIMS and/or managing a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics)
  • Experience with laboratory instrumentation, software and their interfacing is highly desired
  • Thorough knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge a plus
  • Experience with change control and software validation preferred
  • Excellent oral and written communication skills

Desired Experience

  • 3+ years of experience working in an administrative capacity with LIMS. LabWare LIMS, version 6 (or greater) experience highly preferred.

Desired Skills, Experience and Abilities:

  • Experience with cGMPs and data integrity required
  • Solid background running database queries, both for routine and ad hoc purposes
  • Programming experience is a plus (VB, VBA, SQL, ASP and HTML)
  • Ability to work off-shift or weekends as required
  • Knowledge of QC Laboratory and QA in a FDA regulated industry.
  • Knowledge of limits of variability for QC testing and firm grasp of general scientific calculation concepts (e.g. unit conversions, percentages)

SUCCESS FACTORS:

  • Strong communication for both external and internal customers.
  • Passion to provide excellent customer service.
  • Ability to write reports and business correspondences.
  • Ability to communicate succinctly and effectively to key stakeholders.
  • Ability to listen and respond well to external customers, partners, and colleagues at all levels.
  • Excellent time and project management skills as well as ability to meet deadlines.
  • Solid analytical, logical thinking and problem-solving skills.
  • Desire and willingness to troubleshoot issues, communicate procedural gaps and recommend improvements in partnership with IT.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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