Stability Analyst

4 days ago

US Petersburg VA USA Civica Rx Full time
Job Summary

Civica Rx is seeking a highly skilled Stability Analyst to join our team at our Petersburg, Virginia site. As a key member of our quality assurance team, you will be responsible for ensuring the stability program at our site complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.

Key Responsibilities:

  • Establish and maintain the stability program at Civica Rx Petersburg.
  • Generate, review, and approve policies, procedures, reports, protocols, investigation, change controls, and other records necessary for the stability program.
  • Work cross-functionally to support the development and maintenance of the stability program.
  • Author stability protocols for new drug products and annual commitment batches.
  • Build plans for ensuring stability commitments are met.
  • Support the shipment of samples to external testing facilities.
  • Act as primary contact with Contract laboratories to coordinate and monitor stability protocols and testing schedules.
  • Responsible for assessing stability requirements related to changes.
  • Participate or lead 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 as needed.
  • Support overall sample management and Quality Control Operations as needed.
  • Compile and evaluate stability metrics, trend data, and report to Management.
  • Ensure that all aspects of the handling, stability samples at the site comply with Civica Rx and relevant FDA and Drug Enforcement Administration (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/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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