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Quality Control Specialist I (KLIMS), Analytical Operations

美国 - 马里兰州 - 弗雷德里克质量正式员工
应用

职位描述

As a KITE Laboratory Information Management System (KLIMS) Specialist in the Quality Control (QC) Technical Services group, this role will act as one of local KLIMS site support and as a LIMS Administrator back-up for KLIMS related topics to the larger organization. The QC KLIMS Specialist will support both site and global programs priorities to achieve established system functionality goals, in addition to supporting any interactions and communications between site cross-functional personnel (QC, Quality Assurance, Manufacturing, F&E, IT, etc.) and the global program team, as needed.

Overall, this role is responsible for providing the technical support and expertise necessary to build and/or manage maintenance of established Master Data, implementation of new system functionality of the Global LabVantage LIMS system at the site.

Responsibilities

Site Related:

  • Site KLIMS supports system function and use at site:
    • Support and resolve KLIMS issues that impact current operations.
    • Support weekly reagent updates (from ERP for released materials).
    • Support training and use of KLIMS for each function at the site.
    • Generation of site-specific Master Data to support KLIMS functionality rollout at site.
    • Implement Master Data updates/changes related to the site as they arise.
    • Participate in KLIMS maintenance and system upgrade activities.
  • Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team.
  • Supports site specific KLIMS project deliverables (e.g. vertical/functionality delivery)
    • Support best practices on LIMS development, Master data, reporting, and any other configuration.
  • Troubleshoot site related KLIMS issues and escalate to the global team, as necessary.
  • Assist in developing, reviewing, and maintaining site specific, KLIMS related documentation (i.e. SOPs, SPCs, WRKs, URSs).
  • Assist with deviation, investigation, impact assessments, CAPA and change control activities.
  • Support inspections/audits for KLIMS specific topics, requests, or questions.
  • Additional duties as assigned.

Global Related:

  • Participates in global, vertical specific, working and delivery teams.
  • Provide peer review support of Master Data updates generated by other QC KLIMS Admins and backup support for other sites as needed.
  • Review and update local and global SOPs and WRKs related to LIMS, as required.
  • Additional duties as assigned.

Basic Qualifications:

  • Master’s and 2+ years of experience in a GMP environment, OR;
  • Bachelor’s and 4+ years of experience in a GMP environment, OR;
  • Associate and 5+ years of experience in a GMP environment, OR;
  • High School Diploma/GED and 6+ years experience in a GMP environment experience.

Preferred Qualifications:

  • Experience with a Lab Information Management System preferably LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).
  • Demonstrated results implementing LIMS and computer system validation in a cGMP environment.
  • Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
  • General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations.
  • Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
  • Ability work independently, and/or as part of a team with internal and external teams.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Excellent skills in Microsoft Office, MS Project, MS Teams, SharePoint, Smartsheets, data analysis software, and other related applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in an exciting small company environment with minimal direction and able to adjust workload based upon changing priorities.

Does this sound like you? If so apply today!

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