Specialist, Manufacturing - ES RMD QRO

The Specialist, Manufacturing supports the execution and continuous improvement of core manufacturing and quality systems with minimal supervision. This role applies process expertise, operational knowledge, scientific understanding, compliance fundamentals, and strong analytical/troubleshooting skills to ensure robust, efficient, and compliant manufacturing operations.

The Specialist may serve as a primary production process owner for designated support systems and contribute to process ownership responsibilities for more complex systems. The position also plays a key role in non‑conformance management, process validation, procedure governance, training, and new product introduction (NPI) activities.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; act as document owner ensuring alignment with current operations.
• Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
• Provide troubleshooting support to resolve process-related issues.
• Assist in developing training materials and deliver technical/scientific training as needed.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process-monitoring data; assist in deviation assessments.
• Contribute to timely completion of quarterly process monitoring reports.
• Ensure timely triage of non‑conformances within established goals.
• Author investigation reports with clear root cause analysis and corrective actions.
• Execute corrective actions and manage NC/CAPA closure within defined timelines.
• Monitor and communicate incident trends.
• Review equipment/system RCA investigations and support trend evaluations.
• Assist in generating process validation protocols and reports.
• Support execution of validation activities.
• Collect, analyze, and interpret validation data.
• Participate in regulatory inspections, NPIs, and process/equipment modification activities.
• Support NPI assessments related to documentation, materials, training, and equipment needs.
• Provide prioritization, justification, and project management support for process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Serve as the External Supply Quality Record Owner, managing supplier-related Change Control quality records with minimal supervision.
• Lead cross-functional meetings to ensure timely progression and closure of Change Control records.
• Participate in special projects, assessments, and implementation activities as assigned.
• Support noncommercial activity runs for process data collection and analysis.
• Skills
• Strong technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Excellent organizational, technical writing, and presentation abilities.
• Basic project management skills.
• Working knowledge of control charting and data trending.

Requirements

• Doctorate OR
• Master’s + 2 years of Manufacturing Operations experience OR
• Bachelor’s + 4 years of Manufacturing Operations experience OR
• Associate’s + 8 years of Manufacturing Operations experience OR
• High School/GED + 10 years of Manufacturing Operations experience.

Preferred Qualifications

• Demonstrated expertise in Change Control processes, especially supplier-related quality records.
• Hands-on experience with TrackWise and SAP.