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Senior Coordinator of Chemistry Stability
2 months ago
SCA Pharmaceuticals, LLC is a progressive and rapidly expanding organization dedicated to delivering high-quality pharmaceuticals that are essential for preserving and enhancing human health. As an FDA 503B outsourcing facility, we specialize in formulating customized medications for healthcare institutions across the United States. Our unwavering commitment to quality, safety, and integrity drives our mission, alongside a focus on teamwork and innovative solutions.
Position Summary:
The Senior Coordinator of Chemistry Stability plays a crucial role in conducting stability assessments for compounded pharmaceutical products. This position is integral to the Quality Control team, tasked with establishing and overseeing stability studies, ensuring the functionality and validation 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, and must possess a robust understanding of pharmaceutical stability protocols.
Key Responsibilities:
- Deliver comprehensive stability study documentation while ensuring compliance with established plans and timelines.
- Develop stability study protocols, coordinate testing, assess results, and compile final reports.
- Review test outcomes for precision and adherence to cGMP standards.
- Manage stability chambers, including monitoring their operation and coordinating necessary repairs.
- Initiate and oversee investigations related to deviations, corrective actions, and out-of-specification results.
- Assist in addressing stability-related inquiries during audits and implement corrective measures as required.
- Actively seek opportunities to enhance processes, drive efficiency, influence decisions, and achieve results while maintaining compliance.
- Perform additional tasks 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 effectively in a dynamic environment.
- Competence in reviewing, compiling, and analyzing data to create reports.
- Goal-oriented with excellent time management and organizational capabilities.
- Willingness to adhere to all required personal protective equipment (PPE) protocols.
SCA Pharmaceuticals, LLC is an equal opportunity employer. We promote diversity and inclusion in our workforce and do not discriminate based on any protected status.
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