Quality Control Associate II, Sample Management

Location
98011, Bothell
Posted
Sep 03, 2020
Ref
20059
Required Education
Associate Degree
Position Type
Full time

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.

The QC Associate III will support Sample Management at a new immunotherapy manufacturing plant. The candidate will be responsible for movement of samples and materials within the facility, using the Laboratory Information Management System (LIMS). The position is in a regulated environment following current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs).
This role may require occasional weekend, overtime or holiday work to meet the facility manufacturing schedule.

Essential Functions

• Participate in the workflow development and optimization for, QC Sample management, sample chain of custody, QC Contract Lab Data Management and QC/QA Retain Strategy
• Use of a LIMS system to perform all aspects of Sample management including storage, receipt, sample distribution to QC labs, sample shipment to contract laboratories and sample disposal
• Assist in the customization of the LIMS program for the manufacturing plant to support QC in process, and release testing, stability testing and environmental monitoring
• Authoring of Standard Operating Procedures for Sample Management functions
• Coordination of receipt of completed sample test results, collation and submittal for management review and release
• Support coordination of stability testing schedule- sample distribution, testing and reconciliation
• Supports the qualification and validation of the LIMS program as needed
• Perform preventative maintenance and/or equipment monitoring activities as needed
• May perform basic microbiological or analytical testing.

Requirements

• 3+ years of cGMP experience in Sample Management using a LIMS system
• Experience in a cell/gene therapy cGMP manufacturing and testing facility is a plus.
• Understanding of and ability to apply the regulations associated with 21 CFR 210/211

Education:

• AA, BA or BS – a combination of education and work experience may substitute

Additional Skills:

• Good Documentation Practices (GDP) and ALCOA required
• Good organizational and time management skills
• Good oral and written communication for effective interpersonal collaboration
• Ability to work in a team environment and perform job responsibilities with reasonable supervision
• Exceptional attention to detail
• Identify opportunities for operational excellence, application of Lean principles and continuous improvement
• Must be proactive, action oriented and have the ability to adapt to a change

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.