Manufacturing Specialist (3522284) Regulated Industry

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

Manufacturing Specialist (3522284) Regulated Industry

Job Title: Specialist, Manufacturing (3522284)

Work Schedule: 100% Onsite – Administrative Shift

Open Positions: 5

Assignment Duration: Approximately 11 months

Position Summary

Under minimal supervision, the Manufacturing Specialist supports the execution and continuous improvement of manufacturing and quality systems, including non-conformance management, process validation, procedures, training, and new product introductions. This role applies process, operational, and scientific expertise, along with foundational compliance knowledge and strong analytical and troubleshooting skills, to support manufacturing operations. The Specialist may serve as a primary production process owner for designated process support systems and assist with process ownership responsibilities for more complex manufacturing systems.

Preferred Qualifications

• Bachelor’s degree in Science or Engineering (preferred)
• Previous manufacturing experience in a regulated environment
• Hands-on experience managing CAPA and Change Control processes
• Experience with document revisions and document ownership
• Proficiency with Veeva systems

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations.
• Serve as document owner for assigned manufacturing documentation.
• Assess process performance through floor observations and review of performance metrics.
• Identify, evaluate, and implement process improvement opportunities.
• Provide technical and operational troubleshooting support.
• Assist in the development of training materials and support delivery of training on scientific or technical process topics.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data and support deviation assessments.
• Support the timely execution and completion of quarterly process monitoring reports.

Non-Conformance and CAPA Management

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports and supporting documentation.
• Execute assigned corrective and preventive actions.
• Manage NC/CAPA activities to closure within established goals.
• Monitor, trend, and communicate incident and deviation trends.
• Review equipment and system root cause analysis investigations and support trend evaluations.

Process Validation

• Assist in the development of process validation protocols and final reports.
• Support execution of process validation activities.
• Collect, analyze, and summarize process validation data.

Regulatory and Compliance Support

• Participate, as needed, in regulatory inspections, new product introductions (NPI), and process or equipment modifications.
• Support the NPI process by assessing requirements related to documentation, materials, training, and equipment changes.
• Assess, prioritize, justify, and support implementation of process or equipment modification projects, including project management support.

Change Control

• Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.

Projects and Initiatives

• Participate in the assessment, planning, and implementation of special projects and continuous improvement initiatives.
• Perform additional related duties as assigned.

Education Requirements

• Master’s degree plus 2 years of Manufacturing Operations experience OR
• Bachelor’s degree plus 4 years of Manufacturing Operations experience OR
• Associate degree plus 8 years of Manufacturing Operations experience OR
• High School Diploma/GED plus 10 years of Manufacturing Operations experience

Competencies and Skills

• Detailed technical understanding of bioprocessing unit operations
• Proficiency in GMP manufacturing and production operations
• Knowledge of regulatory requirements and inspection support
• Ability to participate in and support cross-functional teams
• Strong communication and collaboration skills with technical and management stakeholders
• Effective organizational, technical writing, and presentation skills
• Basic project management capabilities
• Working knowledge of control charting and process trending