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Senior Coordinator of Chemistry Stability

2 months ago

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

SCA Pharmaceuticals, LLC is a forward-thinking organization dedicated to delivering high-quality pharmaceutical solutions that are essential for preserving and enhancing human health. As an FDA 503B outsourcing facility, we specialize in creating tailored medications for healthcare institutions across the United States, driven by our unwavering commitment to quality, safety, and integrity.

Position Summary:

The Senior Coordinator of Chemistry Stability plays a pivotal role in conducting stability assessments of compounded pharmaceutical products. This position is integral to the Quality Control department, focusing on the establishment and oversight of stability studies, ensuring the validation and functionality of stability equipment, testing samples at designated intervals, and analyzing the resulting data. The ideal candidate will possess extensive knowledge of pharmaceutical stability studies and will be responsible for managing the stability program to substantiate beyond-use dates.

Key Responsibilities:

  • Deliver comprehensive stability study documentation while ensuring compliance with established plans and timelines.
  • Develop stability study protocols, coordinate testing, evaluate outcomes, and compile final reports.
  • Review test results for precision and adherence to current Good Manufacturing Practices (cGMP).
  • Oversee stability chambers, ensuring operational efficiency and coordinating repairs as necessary.
  • Initiate and supervise investigations related to deviations, corrective actions, and results that fall outside of established parameters.
  • Engage in addressing stability-related inquiries during audits and implement corrective measures as required.
  • Continuously seek opportunities to enhance processes, improve efficiency, influence decision-making, and achieve results while maintaining compliance.
  • Perform additional duties as assigned by management.

Qualifications:

  • Bachelor's degree in life sciences, chemistry, or a related discipline.
  • A minimum of 5 years of laboratory experience, particularly with HPLC in an analytical chemistry setting.
  • Experience with sterile injectable products is highly desirable.

Desired Skills and Attributes:

  • Proficient in Microsoft Office Suite (Word, Excel, Outlook).
  • Excellent verbal and written communication skills, with the ability to convey information clearly to various stakeholders.
  • Strong organizational skills with the ability to prioritize and manage multiple tasks in a dynamic environment.
  • Competent in reviewing, compiling, and analyzing data to prepare comprehensive reports.
  • Goal-oriented with effective time management capabilities.
  • Willingness to adhere to all required personal protective equipment (PPE) protocols.

SCA Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion in the workplace.

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