Responsibilities of the Manufacturing Specialist:
- Create and execute Equipment Qualification Protocols (IQ/OQ/PQ), Cleaning and Process Validation protocols and Computerized Systems validation protocols.
- Support project planning, task management, work plan development and execution in support of projects, new product development, and commercial launches.
- Support timelines for specific strategic projects for management.
- Support the communication of and conformance with the Production Schedule based on inventories and sales.
- Support Budgeting, Costing and Accounting Activities.
- Perform Administrative and Clerical Tasks such as creating and editing documents, analysis of data, and batch record/documentation review.
- Support implementation of change controls and corrective actions for investigations, CAPAs and audits.
Requirements of the Manufacturing Specialist:
- Bachelor’s degree and 2+ years relevant project management experience in an FDA regulated industry or an equivalent amount of experience in pharmaceuticals/biotechnology.
- Exceptional technical writing, review and analytical skills.
- Knowledge of good documentation practices and cGMPs.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.