Quality Control Specialist I (KLIMS), Analytical Operations

仕事内容

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. Join Gilead and help create possible, together.

 

Job Description

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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The salary range for this position is: $78,455.00 - $101,530.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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