Pharmaceutical Stability Coordinator

1 week ago


White River Junction, Vermont, United States SCA Pharmaceuticals, LLC Full time
About the Role

The Chemistry Senior Stability Coordinator is a critical member of our Quality Control team at SCA Pharmaceuticals, LLC. This role is responsible for overseeing the stability program, ensuring the accuracy and compliance of stability studies, and providing expert knowledge in pharmaceutical stability studies.

Key Responsibilities
  • Stability Study Management: Develop and implement stability study protocols, coordinate testing, and evaluate results to ensure compliance with cGMP regulations.
  • Equipment Maintenance: Oversee the maintenance and validation of stability equipment, ensuring it is functional and calibrated.
  • Investigation and Resolution: Initiate, perform, and supervise investigations related to deviations, corrective actions, out-of-trend, and out-of-specification results.
  • Compliance and Audits: Participate in stability-related audits, implement corrective actions, and ensure compliance with regulatory requirements.
  • Process Improvement: Identify opportunities for process improvements, increase efficiency, and influence decisions to drive results.
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, with a strong preference for experience with sterile injectable products.
  • Skills: Proficient in Microsoft Office Suite, excellent communication and analytical skills, ability to prioritize and manage multiple tasks, and strong time management and organizational skills.


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