Stability Program Manager
5 days ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.
We are a team of experienced healthcare and pharmaceutical industry leaders, working together to make a difference in the lives of patients. Our organization is committed to Do What Is in the Best Interest of Patients, and we strive to deliver high-quality results while overcoming challenges and focusing on what matters.
Job SummaryThe Stability Analyst will join our team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
The role is essential to assure our stability program complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.
Responsibilities- Work across functions to support the development and maintenance of the stability program at Civica Rx Petersburg.
- Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirements.
- Build plans for ensuring stability commitments are met.
- Support the shipment of samples to the appropriate 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.
- Practice and promote a safety and quality mindset and a quality excellence approach to all activities.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- 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 is required.
- 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.
- Experience with Laboratory Information Management Systems (LIMS).
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US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are a team of experienced healthcare and pharmaceutical industry leaders, working together...
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