Quality Assurance Specialist

3 weeks ago


Maryland, United States ApTask Full time
About the Role

We are seeking a highly skilled Quality Control Chemist to join our team at ApTask. As a leading global provider of workforce solutions and talent acquisition services, we are dedicated to shaping the future of work.

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.
  • 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-specification (OOS) results and participate in determining the 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.
Requirements
  • Bachelor's Degree or equivalent experience in biotechnology or a related field and quality control experience.
  • Strong knowledge of GMP, SOPs, and quality control processes.
  • Identifying, writing, evaluating, and closing OOSs 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).
About ApTask

ApTask is an African American-owned and Veteran-certified company, dedicated to shaping the future of work. We offer a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management.



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