Regulated Manufacturing Specialist - Process & Quality Lead

ProQuality Network; United States; Hybrid; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Manufacturing Specialist (3522284) to support execution and continuous improvement of manufacturing and quality systems on a 100% onsite administrative shift. Open positions: 5; assignment duration ~11 months.

The role involves non-conformance, process validation, training, and new product introductions in a regulated environment. Responsibilities include creating and revising procedures, document ownership, monitoring process performance, and leading CAPA/NC

Qualifications

• Master’s/Bachelor’s/Associate or HS diploma with manufacturing ops experience as listed.
• Experience in regulated manufacturing environments.
• Experience with CAPA and Change Control processes.
• Document revisions and document ownership.
• Proficiency with Veeva systems.

Responsibilities

• Initiate, revise, and approve manufacturing procedures aligned with operations.
• Serve as document owner for assigned manufacturing documentation.
• Assess process performance through floor observations and metrics.
• Identify and implement process improvements.
• Provide technical and operational troubleshooting support.
• Develop training materials and support delivery of training on technical topics.
• Establish process monitoring parameters and control limits.
• Collect and analyze process monitoring data and support deviation assessments.
• Support quarterly process monitoring reports.
• Triage non-conformances within timelines; author investigation reports.
• Execute corrective and preventive actions and close NC/CAPA activities.
• Monitor trends and support root cause analyses.
• Assist in development and execution of validation protocols and reports.
• Support regulatory inspections and NPI processes; assess documentation needs.
• Assist CCRB packages impacting processes.

Education

Master’s degree + 2 years Manufacturing Ops experience

Bachelor’s degree + 4 years Manufacturing Ops experience

Associate degree + 8 years Manufacturing Ops experience

High School Diploma/GED + 10 years Manufacturing Ops experience

Tools

Veeva systems

Job description

ProQuality Network is seeking a Manufacturing Specialist (3522284) to support execution and continuous improvement of manufacturing and quality systems on a 100% onsite administrative shift. Open positions: 5; assignment duration ~11 months.

The role involves non-conformance, process validation, training, and new product introductions in a regulated environment. Responsibilities include creating and revising procedures, document ownership, monitoring process performance, and leading CAPA/NC