Manufacturing Quality Assurance Lead, Pharmaceutical Industry
2 weeks ago
About the Role
We are seeking a highly motivated Quality Technician, Portage Facility Operations to join our team at Ursitti Enterprises LLC. As a key member of our manufacturing team, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:
- Develops and implements quality systems that support manufacturing operations, meeting product and process quality metrics.
- Provides GMP/GDP guidance to ensure proper actions and documentation occur within the manufacturing space.
- Performs product sampling and testing to support drug product manufacturing, troubleshoots quality issues, and issues line-clearances.
- Assists with problem-solving and investigation of nonconformances, real-time and post-manufacturing document reviews, and coordinates workflows and events.
- Partners with operations to lead in developing, implementing, and maintaining quality systems.
Requirements:
- Bachelor's degree in chemistry, biochemistry, or a related science field is preferred.
- At least 3 years of experience in the pharmaceutical industry with increasing responsibility is desired.
- Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
- Technical proficiency in reviewing production records, reports, and GMP-related documentation.
- Able to work within a team environment and contribute to company goals.
- Strong technical writing skills and good problem-solving techniques.
Estimated Salary: $60,000 - $80,000 per annum.
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