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Quality Assurance Specialist

1 month ago


Frederick, Maryland, United States Collabera Full time
Job Summary

We are seeking a highly skilled Quality Control Chemist to join our team at Collabera. The successful candidate will be responsible for performing testing of raw materials, intermediates, and final products using various analytical methods, including cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.

Key Responsibilities
  • Perform testing of raw materials, intermediates, and final products using analytical methods such as 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.
  • 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-specification (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.
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.
  • 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.