Position Summary

The Stability Associate is responsible for executing stability studies of plasma-derived biopharmaceutical products in a cGMP environment.  Areas of focus are planning and executing studies, managing study inventory, and scheduling and performing stability pulls.  Additional stability related support activities include writing protocols, monitoring and trending data, and writing stability reports.

Essential Functions (ES) and Responsibilities

• Responsible for all day-to-day activities of the Quality Control Stability program:
  • Plans and executes stability studies.
  • Manages stability inventories.
  • Schedules and performs stability pulls.
  • Monitors the completion of test data.
  • Performs data verification for stability reports.
  • Supports the management of temperature-controlled chambers.
• Supports and assists in all other aspects of the Quality Control Stability program as needed:
  • Preparation and revision of technical documentation for department areas of responsibility such as Procedures, Stability Protocols, Specifications, etc.
  • Perform and interpret statistical analysis of trends by linear regression, ANCOVA, and control charting using appropriate data analysis software.
  • Preparation and revision of stability data reports with adherence to regulatory and company guidelines.
  • Preparation of thorough change controls and investigations for quality systems.
• Possesses expertise and guides others in cGMP and cGDP practices in documentation and execution of job functions.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements:

A bachelor's or master's degree in Biology, Chemistry, Mathematics, or a related scientific field is required.  

Experience Requirements:     

• Requires at least 1 - 3 years of experience in a regulated laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc.).
• Must be familiar with GLP and GMP guidelines.
• Must have working knowledge of trending and/or stability analysis in a regulated environment.
• Ensures compliance with all regulatory requirements by verifying procedures are being followed, all recordkeeping is current, proper maintenance occurs, and new requirements are identified as they arise.
• Effectively communicates critical stability and quality related information to appropriate teams. 
• Is a subject matter expert for areas of responsibility for internal and external customers and participates in internal and external audits.
• Identifies opportunities for and participates in continuous improvements to increase efficiency and compliance.
• Performs, reviews, and trains on processes performed within the QC department.
• Assists in other QC, regulatory support, and data analysis functions, as assigned by the Manager.
• Analyzes issues and exercises judgment within defined procedures to determine appropriate resolution to problems.
• Reports on non-standard problems with area management.
• Is familiar with Standard Operating Procedures (SOP) writing procedures.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.