MFG Compliance Specialist - LanceSoft Inc
Fremont, CA
About the Job
Number of Positions: 2
Duties:
Skills:
Education:
Experience:
Certifications & Licenses:
Duties:
- 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 biopharmaceuticals. 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:
- Bachelor s degree with a focus in Biopharmaceuticals.
Experience:
- 2 Years Experience with cGMP and biopharma
Certifications & Licenses:
- CAPA
Source : LanceSoft Inc
