Stability Coordinator

4 weeks ago

Santa Ana, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Stability Coordinator

Job Description

The Stability Coordinator will author stability protocols, organize, and manage stability studies in accordance with ICH and FDA guidelines. This role involves initiating stability studies for drug substances and products, maintaining stability equipment, performing stability pulls, coordinating sample preparation/submission and testing, and publishing a monthly stability pull/testing status dashboard. The coordinator will ensure accurate and timely documentation of stability data and maintain stability databases.

Responsibilities
  • Initiate and manage stability studies for drug substances and products.
  • Maintain stability equipment and perform stability pulls.
  • Coordinate sample preparation, submission, and testing.
  • Publish a monthly stability pull/testing status dashboard.
  • Ensure accurate and timely documentation of stability data.
  • Maintain stability databases.
  • Review and analyze stability data to identify trends and report findings to relevant stakeholders.
  • Collaborate with formulation and quality assurance teams to ensure appropriate test methods and protocols are followed.
  • Coordinate with third-party contract labs for scheduling and executing stability studies.
  • Prepare stability reports and participate in regulatory submissions as needed.
  • Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  • Train and mentor team members on stability testing protocols and regulatory requirements.
  • Stay updated on industry trends and regulatory changes related to stability testing.
  • Perform testing of stability samples as needed.
  • Validate analytical methods according to regulatory guidelines (e.g., ICH, FDA).
  • Conduct experiments and analyze data to troubleshoot and improve existing methods.
Essential Skills
  • Quality control
  • Stability testing
  • Chemistry
  • Good Manufacturing Practices (GMP)
  • High-Performance Liquid Chromatography (HPLC)
  • Knowledge of analytical laboratory instrumentation (Analytical Balance, pH meter, HPLC, UPLC, Dissolution testers, KF Titrator)
Additional Skills & Qualifications
  • Bachelor of Science degree in a related field or comparable additional experience.
  • Prefer a minimum of 4-6 years of related industry experience with hands-on instrumental experience and analysis.
  • Experience in managing stability programs, not just testing.
Work Environment

This role involves working in a laboratory setting with analytical laboratory instrumentation such as Analytical Balance, pH meter, HPLC, UPLC, Dissolution testers, and KF Titrator. The work environment adheres to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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