Quality Control Specialist Ii - Frederick, United States - Kite Pharma

Kite Pharma

Verified Company

Frederick, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission

As a KITE Laboratory Information Management System (KLIMS) Administrator in the Quality Control (QC) Technical Services group, this role will act as one of local KLIMS site lead and as the site's 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 sitespecific 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.
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.

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
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.

Basic Qualifications:

Master's and 2+ years of GMP environment experience OR
Bachelor's and 4+ years of GMP environment experience OR
Associate and 5+ years of GMP environment experience OR
High School Diploma/GED and 6+ years of 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 regulat