Temporary - Stability Coordinator

Summary of Position: 

The Stability Coordinator is responsible for all aspects of the stability sample program. The Stability Coordinator initiates and manages stability studies, including protocol development and maintenance, sample handling, and data reporting.

Organization Structure:

The Stability Coordinator reports to the Manager Quality Control.   

Responsibilities:  Primary responsibilities of this role include the following:

1. Regulatory Stability Protocol Management
   1. Create and maintain Regulatory Stability Protocols based on the expected customer registered requirements and in compliance with all current ICH regulatory guidance’s
   2. Work directly with project team and customers to define registered stability commitments for study design, testing requirements, and stability specifications
   3. Calculate sample quantities required for testing by reviewing the applicable test methods, and calculate number of samples required per study based on pack types and storage conditions
   4. Review specification changes for product, API, and packaging components to assess impact to Regulatory Stability Protocols and revise protocols as needed using appropriate change management systems
2. Study Protocol Management
   1. Create, review, and/or approve batch specific stability study protocols and summary report tables
   2. Submit sample request form to be included with the production record
   3. Assign stability study identification numbers and stability sample quantities/storage condition for batch records that include procedures for stability sampling

1. Ensure samples are labeled properly and distribute to appropriate stability chamber(s) for storage
2. Work directly with customers to revise stability study protocols as needed throughout study lifetime
3. Study Scheduling and Implementation
   1. Maintain schedule of stability pulls, testing deadlines, and reporting deadlines
   2. Remove samples from stability chambers and coordinate sample delivery to the appropriate NPI or contract testing laboratory
   3. Deliver stability data to customers
   4. Work directly with customer service, project management, and finance to ensure proper charges made for stability testing
   5. Dispose of samples when study is completed or discontinued
   6. Notify and coordinate with Metrologists in the event of an issue with stability chamber performance
   7. Participate in stability improvement projects
4. Compliance Activities
   1. Participate in audits as needed
   2. Complete corrective and preventive actions assigned by investigations or audit observations
   3. Prepare stability data tables and summary reports as needed for customers to use in their NDA Annual Reports or ongoing regulatory and/or stability data review processes
   4. Review stability summary data tables for compliance and trends. Ensure any stability issues or potential issues are appropriately communicated to laboratory management.
   5. Participate in investigations as needed
5. Additional duties as required 

Qualifications: 

1. BS in chemistry or related field, plus 3-5 years of pharmaceutical QC laboratory experience, or equivalent combination of education and experience
2. Excellent oral and written communication skills
3. Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications
4. Ability to comprehend and follow standard operating procedures and test methods
5. Strong attention to detail and ability to multitask
6. Operates with a sense of urgency in a fast-paced environment
7. Strong organization, communication, and interpersonal skills