What are the responsibilities and job description for the Manufacturing Operations Specialist position at Lyndra Inc?
Manufacturing Operations Specialist
- Responsible for authoring and updating MBRs and Work Instructions
- Authors deviations, change controls and CAPAs associated with manufacturing
- Manufacturing support for Lyndra’s novel extended release of drug delivery technology
- Provide training support for on-boarding of new manufacturing personnel
- Perform and manage the completion of technical review of executed batch records
- Tracking and trending manufacturing KPIs such as batch yield, equipment failures , executed batch record technical review, and manufacturing associated quality systems
Experience and Skills
- Minimum of 2 years working in a GMP manufacturing environment
- High level of understanding and compliance with Clean Room Environment, Good Documentation Practices and Good Manufacturing Practices
- Minimum of 1-2 years of experience with polymer extrusion processes
- Working knowledge of Quality Systems
- Strong oral and written communication skills
- Ability to work in a fast-paced cross-functional work environment
- Strong technical writing skills required to author/revise/review Standard Operating Procedures, Work Instructions, and Master Batch Records
- Excellent computer skills including Word, Excel, and Outlook