Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This position will support in the monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions. Helps to Identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.
Skills
Possesses knowledge in the area of manufacturing bio-pharmaceuticals. Has experience in managing simple to moderate projects, and CAPA. Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions. Has some knowledge of change controls, deviations, project management, and audits/inspections. Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task. Projects are cross functional and the project scope is limited. The specialist should be able to independently influence peers to achieve a common goal. Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)
Time management
Must be able to multi-task and be organized. Experience in biotech, pharmaceutical manufacturing is a requirement. Preferably experience being a manufacturing operator or technician.
Education Bachelors Degree with a focus on Bio-pharmaceuticals.
