Jr Quality Systems Specialist (Regulated Manufacturing)

Richmond, CA (Local candidates only. Onsite*)

$34-45hr ( Weekly pay)

M-F 8am -5pm (Onsite)

6 month contract ( Excellent potential for permanent and extension)

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives! Under the Northern California Quality Assurance Operations team, you will support manufacturing activities including investigations of product non- conformance and deviations, blocking of non- conforming material, batch record and CoA review and release. Leveraging your knowledge of Quality principles, you’ll guide the manufacturing partners in correct path for cause investigation and issue resolution. You’ll provide feedback on best practice for documentation and Quality record updates to reinforce Quality Management System.

How You'll Make An Impact:

• Support company’s top business priority: 3110 BioPharma Demand
• Support batch release for LSG mfg sites
• Support Veeva integration for NorCal (Change Control, Nonconformance Management)
• Verification of Change Control activities
• Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
• Audit preparedness, to reduce audit findings

Requirements

• Associate degree or equivalent in Biology, Chemistry, or related field.
• 2+ years’ experience in a Regulated Manufacturing industry within Medical Devise/Drug/ Or Biotech
• Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Working knowledge of device/drug/biotech manufacturing processes.
• Detail-oriented, excellent organization and project management skills and ability to multitask.
• Decision making, time management, organization, communication, leadership, and computer skills.
• Proficient in Microsoft Office, Visio and Excel
• Salesforce and SAP experience is a pl