QC LIMS Administrator
Description
We are seeking a QC LIMS Administrator that has a passion for leading projects and processes, and is familiar with transformational, situational, and servant leadership concepts. The QC LIMS Administrator will work closely with the Director of Quality Control, QC Technical Services, and IT to help INCOG select and validate its LIMS software platform. Additionally, the LIMS Administrator will be responsible for creating and modifying master data associated with QC instrumentation and QC test methods as well as using LIMS to generate sample labels, perform sample tracking and reconciliation, and scheduling of QC personnel and equipment.
The QC LIMS Administrator will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build. Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC LIMS Administrator will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, customers, suppliers, and partners. The QC LIMS Administrator will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the QC LIMS Administrator will possess a demonstrated ability to influence positive outcomes without direct reporting authority.
Essential Job Functions:
- Help select and validate the LIMS software platform used at INCOG.
- Create INCOG process for generating and maintaining
- Master data for: Test methods, Sample labels, Stability protocols, Environmental monitoring schedules, Intruments, Standards and Reagents
- Certified of Analysis (COA) generation
- Customs LIMS reports
- Partner with the IT Program Manager to implement best practices, develop training, and adoption of the LIMS system. The IT Program Manager will be the lead for the overall system design, system capabilities, and vendor management. The QC LIMS Administrator will be the lead for QC processes and master data development.
- Serve as primary point of contact (POC) for other INCOG departments (Supply Chain, MSAT, Project Management, Validation, Quality Assurance) needing reporting or other data from LIMS.
- Coordinate and design sampling plans and author and issue certificates of analysis templates.
- Participate in material planning and Ready to Execute meetings to provide updates on material sampling and material release.
- Partner with QC laboratory and IT Program Manager to ensure instrument connectivity to LIMS software both during initial procurement, as well as during changes or system upgrades.
- Act as primary point of contact (POC) for technical or system-use needs with LIMS software vendor(s) in conjunction with IT Program Manager.
- Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Special Job Requirements:
- Bachelor’s degree in science or information technology.
- Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, in particular deployment of validated LIMS software platforms.
- First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
- Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, PowerBI, JMP, Minitab, etc.).
- Experience with QC instrumentation.
- Experience with SaaS IT systems.
- Experience with PowerBI.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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