What are the responsibilities and job description for the Regulatory Compliance Specialist position at Tucker Parker Smith Group?
Job Description:
Tucker Parker Smith Group
We are seeking a highly skilled QC Critical Reagents Associate to join our team. In this role, you will be responsible for managing and overseeing the life cycle of critical reagents that power groundbreaking global commercial products.
Key Responsibilities:
- Aquire, prepare, and aliquot critical reagents with precision and care.
- Lead qualification testing coordination with lab teams to ensure top-quality standards.
- Oversee the smooth distribution of reagents across a global network of testing sites.
- Utilize LIMS to track reagent activities, testing progress, and generate actionable insights through trend analysis.
- Maintain and optimize inventories, forecasting future reagent supply needs to keep everything running seamlessly.
- Develop and maintain comprehensive technical documentation, including detailed protocols and qualification reports.
- Champion continuous improvement, bringing fresh ideas to enhance workflows and drive operational efficiencies.
Requirements:
- Bachelor's degree in a related field, or Associate's degree with additional relevant experience.
- 1 years of hands-on laboratory experience.
- Exceptional documentation, written, and verbal communication skills.
- Expertise in Microsoft Word, Excel, and analyzing complex data.
- Experience with reagent preparation, inventory management, and LIMS.
- Knowledge of Good Manufacturing Practices (GMP) and QC principles.
- Familiarity with relevant regulations, including 21CFR, USP, EP, and ICH requirements is preferred.
