Stability Program Manager

4 weeks ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a leading healthcare organization dedicated to providing high-quality generic medications to patients in need. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.

We are committed to delivering exceptional patient care and pursuing excellence in quality and compliance. Our team is passionate about making a positive impact on the lives of patients and communities.

Job Summary

We are seeking a highly skilled Stability Program Manager to join our team at our Petersburg, Virginia site. The successful candidate will be responsible for establishing and maintaining our stability program, ensuring compliance with regulatory requirements and International Council for Harmonization (ICH) guidelines.

Key Responsibilities
  • Develop and implement stability protocols for new drug products and annual commitment batches.
  • Build plans to ensure stability commitments are met.
  • Support the shipment of samples to external testing facilities.
  • Coordinate and monitor stability protocols and testing schedules with contract laboratories.
  • Assess stability requirements related to changes.
  • Participate in stability investigations.
  • Track sample receipt, testing, and obtain results and raw data from contract labs.
  • Build and manage stability data in the LIMS system.
  • Support Annual Product Quality Reviews and Annual Reports by providing relevant stability reports.
  • Support overall sample management and Quality Control Operations.
  • Compile and evaluate stability metrics, trend data, and report to Management.
  • Ensure compliance with Civica Rx and relevant FDA and DEA regulatory requirements.
Requirements
  • Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
  • Experience in managing stability studies.
  • Excellent written and oral communication skills with a strong discipline in Microsoft Programs.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously within established guidelines, procedures, and practices.
  • Committed to delivering high-quality results, overcoming challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share learning.
Preferred Qualifications
  • Experience with Laboratory Information Management Systems (LIMS).

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