Quality Assurance Specialist

4 weeks ago


Frederick, Maryland, United States Intelliswift Software Inc Full time

Job Title: Quality Control Chemist

Job Summary:

We are seeking a highly skilled Quality Control Chemist to join our team at Intelliswift Software Inc. The successful candidate will be responsible for performing testing of raw materials, intermediates, and final products by following analytical methods such as cell-based bioassays, flow cytometry, ELISA, and qPCR assays.

Responsibilities:

  • Perform testing of raw materials, intermediates, and final products by following analytical methods.
  • Work with internal and external resources to maintain the 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.
  • 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.

Qualifications:

  • Bachelor's Degree or equivalent experience in biotechnology or a related field.
  • Strong knowledge of GMP, SOPs, and quality control processes.
  • Identifying, writing, evaluating, and closing OOS's and investigations.
  • Proficient in MS Word, Excel, PowerPoint, 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.
  • Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).


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