Position Summary
This role is essential to assure the manufacturing site’s Stability Program complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.
Responsibilities of the position include working cross-functionally to establish and maintain the stability program. Responsibilities also include but are not limited to the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program.
Essential Duties and Responsibilities
- Work across functions to support the development and maintenance of the stability program at the manufacturing site.
- Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement.
- Build plans for ensuring stability commitments are met.
- Support the shipment of samples to the appropriate external testing facilities.
- Acts 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.
- Supports 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 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.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- 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.
Preferred Qualifications:
- Experience with Laboratory Information Management Systems (LIMS).
