Quality Assurance Specialist

2 months ago


Frederick, Maryland, United States Intelliswift Software Inc Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Intelliswift Software Inc. as a Quality Control Chemist. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our internal and external resources to maintain a high level of quality control.

Key Responsibilities
  • Perform testing of raw materials, intermediates, and final products by following analytical methods, including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
  • Work with internal and external resources to maintain the laboratory in an optimal state, including calibration and routine maintenance of laboratory instruments.
  • 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 the generation of certificates of analysis (CoAs) for product release.
  • Author or revise standard operating procedures (SOPs), qualification/validation protocols, and reports.
  • Assist with laboratory investigations regarding out-of-specification (OOS) results, and participate in the determination of root cause for deviations related to analytical procedures.
  • Provide updates at daily and weekly meetings.
  • Monitor the Good Manufacturing Practice (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.
Requirements
  • 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, 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, and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
  • Preferred: Experience in the biotech and/or pharmaceutical industry.


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