Senior Stability Coordinator
2 weeks ago
SCA Pharmaceuticals, LLC is a dynamic and rapidly growing company that values quality, safety, and integrity. We are seeking a highly skilled Senior Stability Coordinator to join our team.
Job Summary:The Senior Stability Coordinator will be responsible for performing pharmaceutical stability studies of compounded products. This individual will oversee the stability program, ensuring that data is generated to justify beyond-use-dates. The successful candidate will have a strong knowledge of pharmaceutical stability studies and be able to deliver complete stability study packages while ensuring adherence to plans and schedules.
Key Responsibilities:- Create and implement stability study protocols, setting up studies, coordinating testing, evaluating results, and generating final reports.
- Review test results for accuracy and cGMP compliance.
- Own and maintain stability chambers, ensuring they are operational and arranging for repairs when necessary.
- Initiate, perform, and/or supervise investigations related to deviations, corrective actions, out-of-trend, and out-of-specification results.
- Participate in answering stability-related questions during audits and implement corrective actions.
- Proactively identify opportunities to increase efficiency, influence decisions, and deliver results while ensuring compliance.
- Bachelor's degree in life sciences, chemistry, or a related field.
- 5+ years of laboratory experience with HPLC in an analytical chemistry laboratory.
- Experience with sterile-injectable products is strongly preferred.
- Proficient in the Microsoft Office Suite (Word, Excel, Outlook).
- Ability to communicate clearly and effectively, both orally and in writing, to all levels of people inside and outside the company.
- Ability to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
- Ability to review, compile, and analyze information to prepare reports.
- Goal-oriented, with strong time management and organizational skills.
SCA Pharmaceuticals, LLC is an equal opportunity employer (Minorities/Females/Disabled/Veterans). 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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