Associate Director for Quality Control Stability
2 weeks ago
Proclinical is seeking an experienced Associate Director to oversee Quality Control Stability in a compliant program. The successful candidate will be responsible for setting up and overseeing a compliant stability program, leading stability studies, driving continuous improvement, and supporting compliant testing applications for marketing approval and commercial supply.
Key Responsibilities:
- Manage the compliant stability program, including sample management, stability studies, and trending activities.
- Lead and oversee the QC Stability team.
- Write and review SOPs, summary, and trend reports.
- Establish and maintain procedures for a compliant stability program.
- Manage stability chambers setup and equipment validation.
- Lead complex investigations into OOS or OOT results with cross-functional experts.
- Troubleshoot assays and implement solutions to drive continuous improvement.
- Oversee external vendors/contract testing facilities for QC Stability testing needs.
- Create and support execution of stability programs for products.
- Review and complete documentation in accordance with cGMP.
- Handle change control and deviations related to QC Stability.
- Author QC regulatory documentation and assist in regulatory audits/inspections.
- Develop and maintain a culture of continuous improvement within the QC team.
Requirements:
- Degree in Chemistry, Biochemistry, Microbiology, or related science.
- Experience in GLP/GMP environments and laboratory-based testing.
- Management experience in a GMP-regulated environment.
- Strong analytical skills and technical experience in product/raw materials testing.
- Knowledge of statistical packages such as JMP.
- Proficiency in MS Word and Excel.
- Effective communication and organizational skills.
- Ability to work well as a team.
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