Pharmaceutical Stability Coordinator

4 days ago


Windsor, Connecticut, United States SCA Pharmaceuticals, LLC Full time
Job Summary

The Chemistry Senior Stability Coordinator is a key member of the Quality Control team at SCA Pharmaceuticals, LLC. This role is responsible for overseeing the stability program, ensuring the accuracy and compliance of test results, and maintaining the functionality of stability equipment.

Key Responsibilities
  • Stability Study Management: Develop and implement stability study protocols, coordinate testing, and evaluate results to ensure compliance with cGMP regulations.
  • Equipment Maintenance: Monitor and maintain stability chambers, ensuring they are operational and functional at all times.
  • Investigation and Resolution: Initiate, perform, and supervise investigations related to deviations, corrective actions, out-of-trend, and out-of-specification results.
  • Compliance and Quality: Review test results for accuracy and ensure compliance with regulatory requirements.
  • Collaboration and Communication: Participate in audits, answer stability-related questions, and implement corrective actions as needed.
  • Process Improvement: Identify opportunities to increase efficiency, influence decisions, and deliver results while ensuring compliance.
Requirements
  • Education: Bachelor's degree in life sciences, chemistry, or a related field.
  • Experience: 5+ years of laboratory experience with HPLC in an analytical chemistry laboratory.
  • Preferred Qualifications: Experience with sterile-injectable products.
Desired Skills and Abilities
  • Technical Skills: Proficient in the Microsoft Office Suite (Word, Excel, Outlook).
  • Communication and Interpersonal Skills: Ability to communicate clearly and effectively with all levels of people inside and outside the company.
  • Time Management and Organization: Ability to prioritize and manage multiple tasks and projects in a fast-paced environment.
  • Analytical and Problem-Solving Skills: Ability to review, compile, and analyze information to prepare reports.
  • Goal-Oriented and Adaptable: Ability to wear all required PPE and adapt to changing priorities and deadlines.


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