Stability Program Manager
2 weeks ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to addressing the critical shortages of essential generic injectable medications in the United States. Established in 2018 by a coalition of health systems and philanthropic organizations, Civica is committed to ensuring that patients have access to affordable medications. With a growing network of over 55 health systems, representing more than 1,500 hospitals, Civica has made significant strides in reducing drug shortages and high prices.
Position Overview
The Stability Analyst will play a vital role within Civica Rx, contributing to the newly established team at our fill finish facility. This position is essential for ensuring that the Stability Program at our site adheres to all relevant regulatory standards and International Council for Harmonization (ICH) guidelines.
Key Responsibilities
- Collaborate across departments to develop and sustain the stability program.
- Create stability protocols for new pharmaceutical products and annual batches, in compliance with current procedures and regulations.
- Design plans to ensure stability commitments are fulfilled.
- Coordinate the shipment of samples to external testing laboratories.
- Serve as the primary liaison with contract laboratories to oversee stability protocols and testing timelines.
- Evaluate stability requirements associated with changes in processes.
- Lead or participate in stability investigations as necessary.
- Monitor sample receipt, testing, and gather results and raw data from contract labs.
- Manage stability data within the Laboratory Information Management System (LIMS).
- Support Annual Product Quality Reviews by providing relevant stability reports.
- Assist with overall sample management and Quality Control Operations as required.
- Compile and analyze stability metrics and trend data for management reporting.
- Ensure compliance with Civica and relevant FDA and DEA regulations in handling stability samples.
- Promote a culture of safety and quality excellence in all activities.
- Identify and collaboratively resolve issues using risk-based and compliant 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-driven, adaptable, and capable of thriving in a fast-paced environment.
- Ability to work independently while adhering to established guidelines and practices.
- Dedicated to achieving high-quality outcomes and overcoming challenges.
- Committed to continuous learning and skill development.
- Familiarity with Laboratory Information Management Systems (LIMS).
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