Quality Assurance Specialist

1 week ago


Frederick, Maryland, United States LanceSoft Full time
Job Title: Quality Control Chemist

LanceSoft is seeking a highly skilled Quality Control Chemist to join our team. As a Quality Control Chemist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products.

Responsibilities:
  • Perform testing and analysis of raw materials, intermediates, and final products using various 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, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
  • Assist with monitoring and trending data, completing routine record reviews of test data and related documents for in-process testing, drug substance, and drug product release.
  • Maintain laboratory instruments for calibration and routine maintenance, ensuring accuracy and reliability of test results.
  • Author or revise Standard Operating Procedures (SOPs), qualification/validation protocols, and reports, ensuring compliance with regulatory requirements.
  • Participate in laboratory investigations regarding out-of-specification (OOS) results, determining root causes for deviations related to analytical procedures.
  • Provide updates at daily and weekly meetings, ensuring effective communication with the team.
  • Monitor GMP systems in place to ensure compliance with documented policies, reviewing proposed changes to systems, procedures, methods, and submissions to regulatory agencies as necessary.
  • Gather metric information for use in continuous improvement of areas of responsibility.
Requirements:
  • Bachelor's degree in a relevant field, such as biotechnology or chemistry, or equivalent experience.
  • Strong knowledge of GMP, SOPs, and quality control processes.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Proficient in MS Word, Excel, PowerPoint, and other applications.
  • Strong written and verbal communication skills.
  • Well-versed in various analytical techniques, such as flow cytometry, ELISAs, PCR, and cell bioassays.
  • Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).

LanceSoft offers a competitive salary range of $30.00 - $32.00 USD hourly on W2, with a 12-month duration. If you are a motivated and detail-oriented individual with a passion for quality control, we encourage you to apply for this exciting opportunity.



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