Clinical Supply Planning Specialist — GMP & Compliance

Merck; New Jersey; Presencial; USD 65 000 - 103 000; Tempo integral

Resumo da oferta

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,

Qualificações

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

Responsabilidades

• 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.

Conhecimentos

Communication skills

Problem solving

MS Office

Detail oriented

Independent learner

Formação académica

Bachelor's degree

Ferramentas

SAP

Descrição da oferta de emprego

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,