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Quality Assurance Specialist

2 months ago

Frederick, Maryland, United States Collabera Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Collabera. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities
  • Testing and Quality Control: Perform testing of raw materials, intermediates, and final products by following analytical methods, including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
  • Lab Management: Work with internal and external resources to maintain the lab in an optimal state.
  • Data Analysis: 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.
  • Documentation: Supply information to support generation of CoAs for product release.
  • Instrument Maintenance: Maintain laboratory instruments for calibration and routine maintenance.
  • Procedure Development: Author or revise SOPs, qualification/validation protocols, and reports.
  • Investigation and Troubleshooting: Assist with lab investigations regarding out-of-specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
  • Communication: Provide updates at daily and weekly meetings.
  • Regulatory Compliance: Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Change Management: Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Continuous Improvement: Gather metric information for use in continuous improvement of areas of responsibility.
Requirements
  • Education: 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.
  • Skills: 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.