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Chemistry Senior Stability Coordinator
3 months ago
SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.
Summary:
The Chemistry Senior Stability Coordinator is responsible for performing pharmaceutical stability studies of compounded products. The Stability team is part of the Quality Control unit and is responsible for, but not limited to, setting up and monitoring stability studies, ensuring stability equipment is validated and functional, testing samples at pre-determined time points and evaluating results. This individual provides the oversight of the stability program for generating the data to justify beyond-use-dates. Typically, the qualified person has a strong knowledge of pharmaceutical stability studies
Essential functions:
- Deliver complete stability study package while ensuring adherence to plan and schedule.
- Create stability study protocols, setting up studies, coordinating testing, evaluating results, and generating a final report.
- Review of test results for accuracy and cGMP compliance.
- Ownership of stability chambers, which includes monitoring the chambers for operation and arranging for repair 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 question during audit. Redaction and implementation of corrective actions related to those audits
- Proactively looks for opportunities to identify change, increase efficiency, influence decisions, and deliver results while ensuring compliance.
- Other duties as assigned by management.
Required Qualifications & Experience:
- Bachelor’s degree in life sciences, chemistry, or related field
- 5+ years of laboratory experience with HPLC in an analytical chemistry laboratory
- Experience with sterile-injectable products is strongly preferred
Desired Knowledge, Skills, and Abilities:
- 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, including possessing good English speaking/writing skills, fluency, and understandability.
- 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.
- Ability to wear all required PPE
SCA Pharma 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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