Job Summary
The Manufacturing Specialist I is responsible for conducting sterile manufacturing tasks, which encompass drug product formulation, operating equipment, and performing visual inspections while adhering to current Good Manufacturing Practices (cGMP). This position requires meticulous documentation, addressing process-related issues, and engaging in validation and cleaning activities to ensure compliance and product quality.
Responsibilities
- Execute sterile manufacturing operations including formulation and inspection of drug products.
- Operate and maintain manufacturing equipment while ensuring adherence to cGMP standards.
- Document processes accurately to maintain compliance and traceability.
- Report any concerns or deviations observed during the manufacturing process.
- Participate actively in validation and cleaning processes to uphold quality standards.
Qualifications
- High school diploma or GED with 6-8 years of relevant experience, or a bachelor’s degree with 1-3 years of experience in a technical discipline.
- Ability to work effectively in a cleanroom setting.
- Must successfully pass visual acuity assessments.
- Demonstrable mechanical skills and aptitude.
