Senior Coordinator of Chemistry Stability

1 week ago

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

SCA Pharmaceuticals, LLC is a progressive and rapidly expanding organization comprised of dedicated professionals committed to our mission of delivering high-quality medications essential for saving and sustaining human life. As an FDA 503B outsourcing facility, we specialize in providing tailored medications for healthcare institutions across the United States. Our operations are grounded in unwavering quality, safety, and integrity, along with a strong commitment to accountability, teamwork, and innovative solutions.

Position Summary:

The Senior Coordinator of Chemistry Stability plays a crucial role in conducting pharmaceutical stability assessments of compounded products. This position is part of the Quality Control division, responsible for establishing and overseeing stability studies, ensuring the validation and functionality of stability equipment, testing samples at specified intervals, and analyzing results. The individual in this role will oversee the stability program, generating data to support beyond-use dates. A strong background in pharmaceutical stability studies is essential for success in this position.

Key Responsibilities:

  • Deliver comprehensive stability study packages while ensuring compliance with established plans and timelines.
  • Develop stability study protocols, coordinate testing, evaluate outcomes, and produce final reports.
  • Review test results for precision and compliance with current Good Manufacturing Practices (cGMP).
  • Manage stability chambers, including monitoring operations and coordinating repairs as needed.
  • Initiate and oversee investigations related to deviations, corrective actions, and out-of-trend or out-of-specification results.
  • Engage in addressing stability-related inquiries during audits and implement corrective actions as necessary.
  • Continuously seek opportunities to enhance processes, improve efficiency, influence decisions, 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 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).
  • Strong verbal and written communication skills, with the ability to convey information clearly to various stakeholders.
  • Ability to prioritize and manage multiple tasks and projects in a fast-paced environment.
  • Competence in reviewing, compiling, and analyzing data to prepare reports.
  • Goal-oriented with excellent time management and organizational capabilities.
  • Willingness to adhere to all required personal protective equipment (PPE) protocols.

SCA Pharmaceuticals is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

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