QC Specialist II, Quality Control Lab Support - $8,000* Sign On

职位描述

At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.

We are seeking a highly motivated individual to join us as a QC Specialist II, Quality Control Lab Support, reporting to the Manager, Quality Control Lab Support in Frederick, MD. In this role, you will execute tasks associated with Sample Management, Raw Material Release, Shipping, System Administration and other Lab Support QC functions, and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.

** This role will either be Sunday to Wednesday Day shift or Wednesday to Saturday Day Shift **

Responsibilities (include but are not limited to):

• Serve as SME on assigned QC Lab Support processes including LIMS.
• Execute sample receipt, processing, and aliquoting as needed to support in-processing testing, release testing, stability, or retains.
• Work with MM, QA, QC, and Global QC as needed to implement and support requirements around Raw Material sampling, testing and disposition.
• Manage and complete all shipping activities within QC functions.
• Perform System Administration functions for QC Equipment.
• Complete routine review of records including, but not limited to, sample chain of custody, sample processing, logbooks, and other documentation generated within QC Lab Support.
• Conduct training on assigned QC processes.
• Author controlled documents such as SOPs, forms, work instructions, etc., as needed.
• Author deviations, investigations, CAPAs, and change controls as needed.
• Complete required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
• Provide updates at daily and weekly meetings.
• Participate in Lean Lab and other Operational Excellence initiatives in the group.
• Additional duties as assigned.

Basic Qualifications:

• Master’s Degree and 2+ years of experience with Quality Control GMP experience.
• Bachelor’s Degree and 4+ years of experience with Quality Control GMP experience.
• Associate Degree and 5+ years of experience with Quality Control GMP experience.
• High School Degree and 6+ years of experience with Quality Control GMP experience.

Preferred Qualifications:

• Strong knowledge of cGMP requirements and how to apply them in a lab setting.
• Experience with sample chain of custody.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects.
• Proficient in Microsoft Word, Excel, Visio, SmartSheets, and other related applications
• Experience with Quality System records such as Deviations, CAPAs, and Change Controls.
• Ability to effectively negotiate and build collaboration within teams and amongst individuals.
• Excellent interpersonal, verbal, and written communications skills which are essential in this collaborative work environment.
• Comfortable in a fast-paced, small company environment with minimal direction and changing priorities.

Does this sound like you? If so, apply today!

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.