Manufacturing Operations Specialist
Katalyst CRO · Durham, NC · Yesterday
HybridContract
Roles & Responsibilities
- Operate manufacturing equipment following Standard Operating Procedures (SOPs) and batch records.
- Execute manufacturing processes in accordance with Good Manufacturing Practices (GMP) requirements.
- Complete electronic batch documentation accurately.
- Perform equipment cleaning and changeovers.
- Maintain inventory of manufacturing supplies.
- Support deviation investigations and corrective actions.
- Monitor production processes and identify abnormalities.
- Participate in shift handoffs and production meetings.
- Follow all safety and environmental procedures.
- Support continuous process improvement initiatives.
Requirements
- 24+ years of pharmaceutical or biotechnology manufacturing experience.
- Experience working in GMP-regulated facilities.
- Familiarity with electronic batch records and manufacturing systems.
- Experience operating automated manufacturing equipment.
- A degree in biology, Biotechnology, Chemistry, or a related field (Associate or bachelor's degree preferred).