Quality Control Specialist I – Sample Management

Descrizione del lavoro

We are seeking a highly motivated individual to join us as a QC Specialist I for the Quality Control Lab Support group at the Kite TCF05 Facility in Frederick, MD.

In this role, you will follow through tasks associated with Sample Management, Raw Material Release, Shipping, System Administration, Deviation Investigations, 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 be Wed - Sat 3pm – 2am**

Responsibilities (include but are not limited to):

• Serve as SME on assigned QC Lab Support processes including LIMS.
• Follow through processes to support sample receipt and processing for In-Process, Final Product, Retain, Back-up, and Stability samples.
• Work with MM, QA and other QC functions to implement and support requirements around Raw Material sampling, testing and disposition.
• Develop and complete all shipping activities within all QC functions.
• Perform System Administration functions for QC Equipment.
• Complete routine record review of records, e.g., of sample chain of custody, processing, logbooks, and other documentation generated within QC Lab Support.
• Conduct training on assigned QC processes.
• Author controlled documents such as SOPs, forms, etc., as needed.
• Author deviations, investigations, CAPAs and change controls as needed.
• Complete desired 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 OR
• Bachelor’s Degree and at least 2 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• Associate Degree and at least 4 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• High School Degree and at least 5 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory.

Preferred Qualifications:

• Thorough knowledge in applying GMP in QC lab.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects
• Proficient in Microsoft Office, Excel, Visio, and other related applications
• Ability to effectively negotiate and develop collaboration within teams and amongst team members.
• Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
• Comfortable in a fast-paces small company environment with minimal direction and able to adjust workload based on changing priorities.

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

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