Specialist Manufacturing
The Judge Group Inc.

Location: REMOTE
Salary: $25.00 USD Hourly - $45.00 USD Hourly
Description: Our client is currently seeking a Specialist Manufacturing
this role requires a technically skilled professional with at least five years of GMP experience, where hands-on expertise in manufacturing processes, particularly upstream in drug substance, is highly valued. While a scientific degree is preferred, practical experience in GMP environments and managing quality records takes priority. Strong team leadership and facilitation skills are essential for coordinating projects efficiently.

This job will have the following responsibilities:

• 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• Quality Records: Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
  

Qualifications & Requirements:

• Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
• • Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
  

Contact: asheikh@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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