Pharmaceutical Stability Coordinator
2 weeks ago
Civica Rx is a 501(c)(4) social welfare organization founded to address the ongoing shortages of essential generic injectable medications that are critical to patient care in the United States. With over 300 medications reported in shortage, Civica aims to combat the challenges posed by pricing and manufacturing issues that adversely affect patients.
Founded by a coalition of health systems and philanthropic organizations, Civica is dedicated to ensuring that patients have access to affordable medications. The organization has expanded its mission to include reducing pharmacy costs and has launched initiatives to produce affordable biosimilar insulin, ensuring that those in need can access life-sustaining medications without financial burden.
Position Summary
The Stability Analyst will play a pivotal role within Civica Rx, contributing to the establishment of a robust Stability Program at our Petersburg site. This facility is dedicated to the production and supply of vital generic sterile injectable medications.
The primary responsibility of the Stability Analyst is to ensure compliance with regulatory standards and International Council for Harmonization (ICH) guidelines. Key responsibilities include:
- Collaborating across departments to develop and maintain the stability program.
- Creating stability protocols for new drug products and annual batches in accordance with current regulations.
- Formulating plans to meet stability commitments.
- Coordinating the shipment of samples to external testing facilities.
- Acting as the main liaison with contract laboratories to oversee stability protocols and testing timelines.
- Evaluating stability requirements in relation to changes.
- Leading or participating in stability investigations.
- Tracking sample receipt and testing results from contract labs.
- Managing stability data within the Laboratory Information Management System (LIMS).
- Supporting Annual Product Quality Reviews by providing necessary stability reports.
- Assisting with overall sample management and Quality Control Operations.
- Compiling and analyzing stability metrics and trends for management review.
- Ensuring compliance with all relevant regulatory requirements regarding stability sample handling.
- Promoting a culture of safety and quality excellence in all activities.
- Identifying and collaboratively resolving issues through compliant, risk-based approaches.
- Bachelor's degree in a scientific field with at least 8 years of experience in Quality/CGMP within the pharmaceutical sector.
- Proven experience in managing stability studies.
- Strong written and verbal communication skills, with proficiency in Microsoft Office applications.
- Self-motivated and adaptable, thriving in a dynamic environment.
- Ability to work independently while adhering to established guidelines.
- Dedicated to delivering high-quality outcomes and overcoming challenges.
- Committed to continuous learning and skill development.
- Experience with Laboratory Information Management Systems (LIMS).
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