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QC Analytical Lab Ops Specialist I - $8,000* Sign On

United States - Maryland - FrederickQualityRegular

Job Description

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!

Responsibilities (include but are not limited to):

  • Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
  • Work with internal and external resources to maintain lab in an optimal state.
  • Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
  • Maintains laboratory instruments for calibration and routine maintenance
  • Author or revise SOPs, qualification/validation protocols and reports.
  • Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.  
  • Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
    Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Perform other duties as required.
     

Basic Qualifications:

  • Bachelor’s Degree OR
  • AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR
  • High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience

Preferred Qualifications:

  • Strong knowledge of GMP, SOPs and quality control processes.  
  • Identifying, writing, evaluating, and closing OOS’s and investigations.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • Preferred: Experience in the biotech and/or pharmaceutical industry.
  • Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.

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.

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