Quality Control Specialist III (LIMS)

Scorpion Therapeutics; United States; Remote; USD 107,000 - 139,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a QC Specialist III to support its Laboratory Information Management System (KLIMS) program. This role is pivotal in ensuring the quality and functionality of global QC processes, driving program priorities, and managing cross-functional communications. You will be part of a team dedicated to groundbreaking cancer therapies, contributing significantly to the development and maintenance of critical systems. If you are passionate about quality control and eager to make an impact in a fast-paced environment, this opportunity is for you!

Benefits

Company-sponsored medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Discretionary annual bonus

Stock-based long-term incentives

Qualifications

• 3+ years of experience with LIMS in a GMP environment.
• Excellent technical writing skills in a regulatory environment.
• Ability to lead discussions and work independently.

Responsibilities

• Support and resolve KLIMS issues impacting global operations.
• Coordinate communication for KLIMS related information.
• Execute Master Data updates and provide peer review support.

Skills

LIMS (Lab Information Management Systems)

Analytical Assays

Quality Control

Technical Writing

Microsoft Office

Data Management

Root Cause Analysis

Change Control

Education

Master’s Degree

Bachelor’s Degree

Tools

LabVantage

MS Project

MS Teams

SharePoint

Smartsheets

Job description

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We’re here for one reason and one reason only – to cure cancer

Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Leadership and Culture

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 Kite and help create more tomorrows.

Job Description

As a QC Specialist III supporting the KITE Laboratory Information Management System (KLIMS) program in the Corporate Quality Control (QC) group, this role will work within the Global QC KLIMS team to deliver and maintain KLIMS Global 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 global program team. Overall, this role is responsible for providing the technical expertise necessary to communicate and/or support maintenance of the established Global KLIMS program, related processes, and implementation of new system functionality of the Global LabVantage LIMS system as it relates to the Global QC network.

This role can be based out of our sites in Frederick, Maryland or Santa Monica, CA and is expected to work West Coast hours.

Responsibilities

Global Related:

• Support and resolve Kite LIMS (KLIMS) issues that impact 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, 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
• Review and update global SOPs and WRKs related to KLIMS, as required.
• Core QC LIMS Administrator oversees system function and use at all sites as they relate to the global processes.
• Troubleshoot site related KLIMS issues in collaboration with the Site QC 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 global 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 all sites 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 global KLIMS functionality rollout at each 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!

The salary range for this position is: $107,185.00 - $138,710.00. Kite 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.

Company Overview

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter.

Equal Employment Opportunity

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

Employee Rights

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.