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Quality Control Chemist - I

Quality Control Chemist - I

Spectraforce TechnologiesFrederick, MD, United States
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Job Title : Quality Control Chemist - I

Duration : 04 months

Location : Frederick, MD 21704

Onsite - Shift flexibility preferred

  • Wed-Saturday
  • Time : Day or Swing shift pending

Description :

IMPORTANT : For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete

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.
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    Quality Control Chemist • Frederick, MD, United States

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