Quality Control Specialist III (KLIMS), Analytical Operations

Описание вакансии

As a QC Specialist III supporting the KITE Laboratory Information Management System (KLIMS) program in the Quality Control (QC) group, this role will work within the Global QC KLIMS team to deliver and maintain KLIMS QC master data and provide support to the KLIMS program as needed.

The QC Specialist III will help drive global program priorities to achieve established system functionality goals, in addition to managing interactions and communications between site cross-functional personnel (QC, Quality Assurance, Warehouse, IT, etc.) as it relates to QC processes and the Fredrick site team.

Overall, this role is responsible for providing the technical expertise necessary to communicate and/or support maintenance of the established local site KLIMS program, related processes, and implementation of new system functionality of the LabVantage LIMS system as it relates to the Global and local site QC network.

This role is based out of our site in Frederick, Maryland.

Responsibilities

Global Related:

• General
  • Support and resolve Kite LIMS (KLIMS) issues that impact TCF05 site and global operations.
  • Provide timely program level reporting on global KLIMS projects and/or Master Data update efforts (e.g. schedule adherence, risk awareness, issue escalation, etc.)
  • Serve as coordination and communication conduit for KLIMS related information between site business users, site IT, network site QC KLIMS Administrator and the Global KLIMS Program including but not limited to:
    • Business Process Change Requirements
    • System Outages (planned and/or unplanned)
    • Training Facilitation
    • Issue/Risk Escalation
    • Lessons Learned
    • Build KLIMS test methods
  • Review and update site KLIMS SOPs and WRKs related to KLIMS, as required.
  • Core QC LIMS Administrator oversees system function and use at the sites as they relate to the global processes.
  • Troubleshoot site related KLIMS issues in collaboration with the Global KLIMS Administrator and escalate to the global team as necessary.

• Quality Management System
  • Support Quality Management System records (i.e., Deviations, CAPAs, Change Controls) related to KLIMS.
  • Provide Change Control support, as required. Including but not limited to Master Data and/or technical impact assessments.
  • Coordinate and perform root cause analysis on complex deviations, document the appropriate CAPA, and ensure that the resolution is effective.
  • Support inspections/audits for KLIMS specific topics, requests, or questions.

• Projects
  • Supports KLIMS at the TCF05 site for the QC network and global program.
  • Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team.
  • Work with business partners to raise enhancement requests and support business case development.
  • Active participation in global, workstream and delivery teams providing required input/feedback to ensure a successful evaluation and delivery of program enhancements.
  • Obtain cross-functional alignment on KLIMS related project requirements and resources to facilitate implementation and ongoing support.
  • Collaborate with QC KLIMS Admin Team to share global network specific knowledge and identify opportunities for improved global management and alignment of KLIMS application.

• Master Data
  • Execute Master Data updates/changes related to global network as they arise.
  • Provide peer review support of Master Data updates generated by other QC KLIMS Admins and backup support for other sites as needed.
  • Generate any site-specific Master Data to support KLIMS functionality rollout at the TCF05 site.

Basic Qualifications:

• Master’s Degree and 3+ years’ experience with LIMS (Lab Information Management Systems) in a GMP environment OR
• Bachelor’s Degree and 5+ years’ experience with LIMS (Lab Information Management Systems) in a GMP environment OR

Preferred Qualifications:

• LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).
• Familiarity with data review for routine analytical assays commonly performed on in QC laboratories; knowledge of more complex analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR is a plus.
• 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 to critically think, lead complex topics in discussion, 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 a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you? If so, apply today!