United States Remote (Country) Full-time

EX Squared is hiring an Analytical QA Associate III (Remote - US)

About the Role

Jobgether is looking for an Analytical QA Associate III to ensure the quality and compliance of pharmaceutical products within a cGMP laboratory environment. You will review, verify, and maintain laboratory documentation, monitor adherence to Good Laboratory Practices (GLP), and support cross-functional teams to meet stringent regulatory and quality standards.

What You'll Do

  • Review and confirm compliance of analytical documents for raw materials, in-process, and finished products.
  • Monitor laboratory personnel to ensure adherence to cGLP procedures and protocols.
  • Evaluate method validation, verification, comparison reports, and other study documentation for compliance.
  • Prepare and review laboratory investigation reports, including OOS, OOT, and deviations.
  • Verify laboratory reagents, chemicals, and standards according to SOPs.
  • Implement Pharmacopoeia changes and ensure alignment with regulatory requirements.
  • Participate in laboratory audit reviews and cross-functional coordination to provide necessary documentation.
  • Maintain proper tracking, recording, storage, and archival of laboratory documents.
  • Identify system gaps during monitoring and suggest improvements to supervisors.
  • Support departmental and cross-functional projects and assignments as needed.

What We're Looking For

  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
  • 5–8 years of analytical experience.
  • Minimum of 3 years in analytical quality assurance.
  • Proficiency with Microsoft Office and quality management software applications.
  • Strong knowledge of laboratory practices including APIs, drug products, analytical development, QC, GLP/GMP/GDP, and USP monograph requirements.
  • Understanding of laboratory equipment operations, qualifications, calibrations, and audit trail reviews (e.g., HPLC, GC, UV-Vis, pH meters, stability chambers).
  • Familiarity with FDA and ICH guidance requirements.
  • Strong technical writing and documentation skills.
  • Excellent interpersonal, communication, and teamwork abilities.
  • Ability to work in a fast-paced, dynamic manufacturing environment with minimal supervision.

Nice to Have

  • Master’s degree.
  • Experience in inhalation products (MDI).

Benefits & Compensation

  • Salary range: $72,800 – $93,600
  • Comprehensive health, dental, and vision coverage.
  • Paid time off and holidays.
  • Opportunities for professional development and training.
  • Collaborative work environment with cross-functional exposure.
  • Experience in a cGMP-compliant laboratory setting.

Work Mode

This is a remote position open to candidates located within the United States.

Jobgether is an equal opportunity employer.

Required Skills
Test AutomationSeleniumCypressPlaywrightAPI TestingPostmanSQLAgile MethodologiesJIRATest Case DesignDefect TrackingPerformance TestingSecurity Testing
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About company
EX Squared

Technology company focused on IT and software solutions

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Job Details
Category qa_testing
Posted 4 months ago