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.

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The primary location for this posting is:

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.