Associate Specialist, Planning & Scheduling - Clinical Supply Operations - 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, batch-record reviews, inspection readiness, incident and complaint documentation, continuous improvement, corrective and preventive actions, KPI monitoring, and collaboration with internal partner groups. It also involves administrative recordkeeping and reporting, completing documentation in accordance with Good Documentation Practices, and maintaining required training and compliance with site safety and quality requirements.
Requirements
- Bachelor’s degree.
- One or more years 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-oriented with organizational skills.
- Ability to learn quickly and complete tasks independently with minimal guidance after training.
- Knowledge of cGMPs and data management, collection, and analysis.
Nice To Haves
- A degree in operations management, engineering, supply chain, or a related technical field.
- Specific experience in clinical packaging.
- SAP or equivalent experience.
- Experience or skills in 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.
- Execute and document SAP transactions accurately and perform pre-execution and post-execution reviews of batch records.
- Support inspection readiness through routine walkthroughs of areas and processes, identifying improvement opportunities and ensuring compliance with regulatory expectations.
- Author or contribute to documentation 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, assess trends, and support root cause analysis for missed targets.
- Collaborate with Quality, Label Room, Distribution Center, Operations Planning, Master Planning, and other internal partner groups.
- 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.
Benefits
- Medical, dental, and vision healthcare benefits
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
