Specialist Manufacturing

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

Key Responsibilities

• Initiate, revise, and approve manufacturing procedures, ensuring all documents accurately reflect current operations.
• Serve as document owner and maintain controlled documentation to ensure compliance with GMP requirements.
• Assess process performance by reviewing floor operations and data trends; identify, plan, and implement process improvement opportunities.
• Provide troubleshooting support for technical and operational issues.
• Assist in developing training materials and deliver training on scientific or technical aspects of manufacturing processes.
• Support establishment and maintenance of process monitoring parameters and control limits.
• Collect and analyze process monitoring data; assist in assessing deviations and compiling quarterly monitoring reports.
• Triage and manage non-conformances (NCs) within established timelines.
• Author detailed investigation reports and execute corrective and preventive actions (CAPAs).
• Ensure timely closure of NC/CAPA records and communicate trend analyses to relevant stakeholders.
• Review equipment and system root cause analyses to support trend evaluation and continuous improvement.
• Assist with authoring and execution of process validation protocols and reports.
• Support data collection, analysis, and interpretation during process validation activities to ensure compliance and robustness.
• Support audit readiness and may participate in internal or regulatory inspections.
• Ensure compliance with current Good Manufacturing Practices (cGMPs) and company quality standards.
• Participate in new product introduction (NPI) activities, including documentation, materials readiness, equipment modifications, and training.
• Evaluate and prioritize process or equipment modification projects and provide project management support throughout implementation.
• Assist in preparing and executing change control packages (CCRBs) affecting manufacturing processes or equipment.
• Participate in special projects, assessments, or continuous improvement initiatives within manufacturing operations.

Requirements

Education:

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

Preferred Qualifications

• Experience writing and revising Standard Operating Procedures (SOPs).
• Hands-on experience with equipment operation, process setup, and optimization.
• Proven ability to create and implement new SOPs and train manufacturing personnel.
• Demonstrated success supporting new product introductions and process validation activities.
• Excellent attention to detail and adherence to compliance standards.

Benefits

• 8-hour shift; overtime as required based on business needs.

• 1 year contract
• Non-Standard Shift