Manufacturing Specialist *PC 555

About the role

This position supports the Manufacturing Operation. Key responsibilities include responding to manufacturing-related quality events, overseeing process improvement initiatives, and providing technical support under cGMP conditions.

Responsibilities

• Ensure proper documentation and timely completion of Manufacturing-related Quality Events (QEs).
• Oversee the development, writing, and review of SOPs, SMPs, BPRs, and other GMP documentation.
• Perform manufacturing reviews of logbooks and executed records.
• Participate in internal and external audits as a manufacturing SME.
• Adhere to clean room SOPs for gowning, traffic flows, and modes of operation.
• Provide technical and operational leadership, assist in operations execution, and provide day-to-day supervision to junior staff.
• Lead process improvement initiatives using Lean Principles.
• Support performance management metrics.
• Assure successful operations through various manufacturing activities.

Requirements

• Bachelor's Degree from a four-year college or university.
• At least 2 years of related experience in a GMP or research manufacturing environment.