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

MSD•Rahway, NJ

2d•Onsite

About The Position

Global Clinical Supply Operations is seeking a motivated, detail-oriented Associate Specialist to support clinical supply packaging operations. The role partners with supervisors and cross-functional stakeholders to ensure clinical operations are executed compliantly, efficiently, and in an inspection-ready manner. A strong commitment to regulatory compliance, quality, and adherence to global and site-specific procedures is essential. The position supports packaging-room and batch preparation, packaging documentation, SAP transactions, and batch-record reviews. It also helps maintain inspection readiness, supports investigation and corrective-action activities, monitors operational performance, and contributes to continuous improvement. The role collaborates with Quality, Label Room, Distribution Center, Operations Planning, and Master Planning. It is based at the primary location in Rahway, New Jersey, is listed as a first-shift/day position, and requires 10% travel. Flexible work arrangements are not applicable.

Requirements

Bachelor’s degree.
At least one year of experience in Technical Operations, related Business Operations, or a GMP-regulated environment.
Effective interpersonal and communication skills.
Demonstrated problem-solving skills.
Proficiency in Microsoft Office, including Word and Excel.
Detail orientation and organizational skills.
Ability to learn quickly and complete tasks independently with minimal guidance after training.
Knowledge of cGMPs and data management, collection, and analysis.
Required skills include batch production records, clinical supplies management, compliance packaging, continuous improvement techniques, detail orientation, driving continuous improvement, Good Manufacturing Practices, operational efficiency, pharmaceutical packaging, and SAP products.

Nice To Haves

A degree in operations management, engineering, supply chain, or a related technical field.
Specific experience in clinical packaging.
Experience with SAP or an equivalent system.
Preferred skills include clinical manufacturing, inspection readiness, and supply chain processes.

Responsibilities

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