Varite-posted 2 months ago
$25 - $29/Yr
Frederick, MD
251-500 employees
Professional, Scientific, and Technical Services

This position involves performing testing of raw materials, intermediates, and final products using various analytical methods. The contractor will work with both internal and external resources to maintain the laboratory in an optimal state and assist with monitoring and trending data. The role requires completing routine record reviews of test data and related documents for in-process testing, drug substance, and drug product release. Additionally, the contractor will be responsible for maintaining laboratory instruments, authoring or revising SOPs, and assisting with lab investigations regarding out of specification results. The position also includes providing updates at daily and weekly meetings and ensuring compliance with GMP systems.

  • 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.
  • Maintain laboratory instruments for calibration and routine maintenance.
  • Author or revise SOPs, qualification/validation protocols and reports.
  • Assist 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.
  • 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
  • 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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