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Quality Control, Lab Operations Technician II

United States - Maryland - FrederickQualityRegular

Arbeitsbeschreibung

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated individual to join us as a Lab Ops Tech II of Quality Control Analytical team in our commercial cell therapy production center located in Frederick, MD. In this role, you will work within the Quality Control Department in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible for maintaining the QC laboratory manage QC samples from manufacturing for QC testing, to maintain lab equipment operation and to support for business operations.

** Shift is M-F 8am-4:30pm **

Responsibilities (include but are not limited to):

  • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays
  • Work with internal resources to maintain lab in an optimal state by maintaining a clean, tidy and, above all, safe work environment.
  • Perform general laboratory duties such as aliquoting, media preparation, equipment maintenance,
  • Track and test products according to test methods and protocols. Testing can include cell counts, pH, osmolality, and others as assigned
  • Troubleshoot fairly standard issues and identify when a deviation from standard process occurs
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Data entry and review
  • Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Additional duties as assigned

Basic Qualifications:

  • AA Degree and 1+ years’ experience in regulated pharmaceutical/Biotech environments or similar role OR
  • High School Degree and 2+ years’ experience in in regulated pharmaceutical/Biotech environments or similar role

Preferred Qualifications:

  • Experience in Quality Control.
  • Experience in aseptic techniques and clean room operations
  • Strong knowledge of GMP, GDP, SOPs and quality control processes
  • Maintain data integrity and ensure compliance with company policy, SOPs, WIs and specifications
  • Excellent interpersonal, verbal and written communication skills in this collaborative work environment.
  • Comfortable in a fast-paced Biopharmaceutical environment with minimal direction and able to adjust workload based upon changing priorities
  • Experience with sample chain of custody, general lab procedures such as operating centrifuges, working in a Biological Safety Cabinet and experience with inventory and laboratory management systems such as LabVantage (LIMS) or similar.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Job requires some overtime, weekend or holiday work as needed.

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

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