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Quality Assurance Specialist

1 month ago

Frederick, Maryland, United States Collabera Full time
Job Summary:

Collabera is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products. You will work closely with internal and external resources to maintain a high level of quality and compliance with regulatory requirements.

Key Responsibilities:
  • Perform testing and analysis of raw materials, intermediates, and final products using various analytical techniques such as cell-based bioassays, flow cytometry, ELISA, and PCR.
  • Work with internal and external resources to maintain a high level of quality and compliance with regulatory requirements.
  • 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 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.

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 Qualifications:
  • Experience in the biotech and/or pharmaceutical industry.