QC Specialist II - (LIMS Administrator Quality Control ) - $8,000* Sign On

Job Description

As a KITE Laboratory Information Management System (KLIMS) Administrator in the Quality Control (QC) Technical Services group, this role will act as the local KLIMS site lead and as the site’s primary point of contact for KLIMS related topics to the larger organization. The QC KLIMS Administrator will coordinate and drive both site and global programs priorities to achieve established system functionality goals, in addition to managing interactions and communications between site cross-functional personnel (QC, Quality Assurance, Manufacturing, F&E, IT, etc.) and the global program team. Overall, this role is responsible for providing the technical expertise necessary to communicate, plan, 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
  • Execute Master Data updates/changes related to the site as they arise
  • Participate in KLIMS maintenance and system upgrade activities.
• Coordination and communication conduit for KLIMS related information between site business users, site IT, 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
• Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team
• Plan, coordinate, and 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.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Global Related:

• Participates as KLIMS point of contact at the site for the QC network and global program
• Participates in global, vertical specific, working and delivery teams
• Collaborate with global QC KLIMS Admin Team to share site specific knowledge and identify opportunities for improved global management and alignment of LIMS application
• 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 global SOPs and WRKs related to LIMS, as required
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• Master’s Degree and 2+ years’ experience in Biotech / Biopharma, GMP Manufacturing OR
• Bachelor’s Degree and 4+ years’ experience in Biotech / Biopharma, GMP Manufacturing OR
• AA Degree and 5+ years’ experience in Biotech / Biopharma, GMP Manufacturing OR
• High School Degree and 6+ years’ experience in Biotech / Biopharma, GMP Manufacturing

Preferred Qualifications:

• 5+ years of experience, preferably in a GMP environment
• Experience with a Lab Information Management System preferably LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).
• Demonstrated success 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 to 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

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.