Associate Specialist, Planning & Scheduling - Clinical Supply Operations - Onsite

Summary

Global Clinical Supply Operations (CSO) is seeking a motivated and detail-oriented Associate Specialist to support clinical supply packaging operations. In this role, you will partner closely with supervisors and cross-functional stakeholders to ensure clinical operation activities are executed in a compliant, efficient, and inspection-ready manner. A strong commitment to regulatory compliance, quality, and adherence to global and site-specific procedures is essential.

Core Responsibilities

• Partner with Supervisors and Senior Packaging Technicians to prepare rooms and batches for packaging operations, including the development of required packaging documentation.
• Ensure accurate execution and documentation of SAP transactions and perform pre-execution and post-execution reviews of batch records.
• Support and maintain inspection readiness through routine walkthroughs of areas and processes to identify opportunities for improvement and ensure compliance with regulatory expectations.
• Author and/or contribute to incidents of atypical events and clinical complaints, as needed.
• Participate in continuous improvement initiatives to enhance operational efficiency and compliance.
• Support corrective and preventive actions resulting from walkthrough observations and investigations, as needed.
• Monitor area performance against key performance indicators (KPIs), assess trends, and support root cause analysis for missed targets.
• Collaborate effectively with internal partner groups, including Quality, Label Room, Distribution Center, Operations Planning, and Master Planning.
• Complete all documentation in accordance with Good Documentation Practices (GDP).
• Maintain current training and compliance with site safety and quality requirements.
• Perform administrative tasks as needed, including archiving, data entry, recordkeeping, and preparation of metrics reports.

Minimum/Preferred Education

Bachelor's degree. A degree in operations management, engineering, supply chain, or related technical field is preferred.

Experience & Skills

• One or more years' experience in Technical Operations, related Business Operations or GMP regulated environment, with specific experience in clinical packaging preferred.
• Effective interpersonal and communication skills.
• Demonstrated problem-solving skills.
• Proficient in Microsoft Office (Word, Excel, etc.).
• Detail-oriented and organization skills.
• Ability to quickly learn and complete tasks independently with minimal guidance after training.
• Knowledge of cGMPs, data management, collection and analysis.
• SAP (or equivalent) experience strongly preferred.

Required Skills

Batch Production Records, Clinical Supplies Management, Compliance Packaging, Continuous Improvement Techniques, Detail-Oriented, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Operational Efficiency, Pharmaceutical Packaging, SAP Products

Preferred Skills

Clinical Manufacturing, Inspection Readiness, Supply Chain Processes