Associate Specialist, Planning & Scheduling - Clinical Supply Operations - Onsite
Merck
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.
Job description
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.
Requirements
- Bachelor’s degree
- One or more years’ experience in Technical Operations, related Business Operations or GMP regulated environment
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Other Insurance Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Leave
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.