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

Merck; New Jersey; On-site; USD 65,000 - 103,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Associate Specialist to support clinical packaging operations. You will partner with supervisors to prepare rooms and batches, ensure accurate SAP transactions, and contribute to inspection readiness and continuous improvement initiatives.

The role emphasizes regulatory compliance and documentation discipline. Candidates should have a Bachelor's degree and 1+ years in GMP or clinical packaging environments, with strong interpersonal and problem-solving skills,

Qualifications

• One or more years of experience in Technical Operations, GMP regulated environment, or related field.

Responsibilities

• Partner with Supervisors and Senior Packaging Technicians to prepare rooms and batches for packaging operations and document accordingly.
• Ensure accurate SAP transactions and perform pre-/post-execution reviews of batch records.
• Support inspection readiness through routine walk-throughs and regulatory compliance.
• Contribute to incidents of atypical events and clinical complaints as needed.
• Participate in continuous improvement initiatives to enhance efficiency and compliance.
• Support CAPA actions from observations and investigations.
• Monitor KPIs, identify trends, and assist with root-cause analysis for missed targets.
• Collaborate with Quality, Label Room, DC, Operations Planning, and Master Planning.
• Maintain GDP-compliant documentation and training records.
• Perform data entry, archiving, and metrics reporting.

Skills

Communication skills

Problem solving

MS Office

Detail oriented

Independent learner

Education

Bachelor's degree

Tools

SAP

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.

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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - New Jersey - Rahway

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

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

$65,100.00 - $102,500.00

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