GMP Production Technician
2 weeks ago
Position: GMP Production Technician
Location: Frederick, MD
Contract Duration: 12 Months
Role Overview
The GMP Production Technician will be responsible for executing and verifying all activities related to the production of commercial products in accordance with established batch records and standard operating procedures (SOPs). This role is crucial for maintaining safe and compliant operations while collaborating closely with teams in Materials Management, Quality Control, and Quality Assurance.
Key Responsibilities:
- Effectively troubleshoot processing and equipment challenges, ensuring timely communication of issues to management.
- Complete necessary training to uphold essential technical skills and knowledge, ensuring adherence to current Good Manufacturing Practices (cGMP).
- Draft and/or update SOPs that are technically robust, providing clear guidance to comply with cGMP standards and enhance operational efficiency.
- Regularly monitor, clean, prepare, and operate advanced automated cell processing, cell expansion, and filling machinery within controlled clean room environments.
- Utilize all required personal protective equipment (PPE) and follow gowning procedures for classified GMP manufacturing areas as provided by the organization.
- Identify opportunities for enhancing manufacturing efficiency and compliance, assisting with investigations, deviations, and change controls.
Essential Qualifications:
- Bachelor's degree in a scientific discipline.
- Associate's degree with a minimum of 1 year of cGMP experience.
- High school diploma with at least 2 years of cGMP experience.
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