1st Shift: Mon-Fri, 8:00AM-5:00PM

$35 - $47.50

6 month extendable CONTRACT

Fremont, CA - onsite

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:

• Bachelors Degree with a focus in Biopharmaceuticals.

Experience:

• 2 Years Experience with cGMP and biopharma - MUST HAVE