Specialist Manufacturing

The Specialist Manufacturing supports the execution and continuous improvement of manufacturing and quality systems with minimal supervision. This role applies scientific, operational, and compliance knowledge to support manufacturing operations, including non-conformances, process validation, procedures, training, and new product introductions. The specialist contributes to process ownership activities, troubleshooting efforts, and process monitoring to ensure efficient, compliant, and reliable manufacturing performance.

Key Responsibilities

• Initiate, revise, review, and approve manufacturing procedures to ensure alignment with current operations; serve as document owner when applicable.
• Monitor manufacturing floor operations and analyze performance data to assess process effectiveness.
• Identify process improvement opportunities and implement corrective or optimization actions.
• Provide technical troubleshooting support for manufacturing processes and systems.
• Assist in developing technical training materials and support delivery of process-related training.
• Support establishment of process monitoring parameters and control limits.
• Collect, analyze, and interpret process monitoring data.
• Assist with deviation assessments and ensure appropriate follow-up actions.
• Support preparation and execution of periodic process monitoring reports.
• Ensure timely triage, investigation, and closure of non-conformances.
• Author investigation reports and document findings.
• Execute and track corrective and preventive actions (CAPA).
• Monitor trends and communicate recurring issues or systemic concerns.
• Support root cause analysis and trend evaluation activities.
• Assist with development and execution of process validation protocols and reports.
• Support validation activities through data collection, analysis, and documentation.
• Ensure validation activities meet regulatory and quality requirements.
• Maintain compliance with GMP and regulatory standards.
• Support regulatory inspections and audit readiness activities as needed.
• Participate in new product introduction (NPI) activities.
• Evaluate requirements related to documentation, materials, training, and equipment.
• Support implementation of process and equipment modifications.
• Assist with project planning, coordination, and execution.
• Support change control processes impacting manufacturing operations.
• Assist change owners in preparing and managing change control documentation.
• Participate in continuous improvement initiatives and special projects.

Requirements:
Education and Experience

• Doctorate degree, OR
• Master's degree with 3 years of manufacturing operations experience, OR
• Bachelor's degree with 5 years of manufacturing operations experience, OR
• Associate’s degree with 10 years of manufacturing operations experience, OR
• High school diploma / GED with 12 years of manufacturing operations experience

Required Skills and Competencies

• Experience working in GMP-regulated manufacturing environments.
• Strong technical writing and documentation skills.
• Basic project management capabilities.
• Familiarity with process monitoring tools and control charting.

Benefits:
• Administrative Shift
• 8-hour shift