MFG Compliance Specialist

Fremont, CA Contract Duration: 6-36 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a MFG Compliance Specialist in the Fremont, CA area. Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. Will support in the monitoring, reporting of deviations, change controls and improvement projects. Responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions. Helps to Identify areas for Continuous Process Improvement and apply operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains. 1st Shift: Mon-Fri, 8:00AM-5:00PM Experience: Bachelor's Degree with a focus in Biopharmaceuticals. 2 Years of experience with cGMP and biopharma Possesses knowledge in 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 and Pharmaceutical Manufacturing is a requirement. Preferably experience being a manufacturing operator or technician.

Created: 2026-03-10