Manufacturing Systems Specialist

Merck•Indianapolis, IN

78d

About The Position

In this role you will play a critical role in ensuring the efficient and compliant operation of manufacturing systems within the pharmaceutical/biotech industry. Responsibilities include but are not limited to: Collecting and analyzing data to identify trends, performance metrics, and areas for improvement within the manufacturing systems. Reviewing batch records to support product release, ensuring accuracy, compliance, and adherence to quality standards. Investigating and writing deviations, ensuring thorough documentation and timely resolution to maintain product quality and compliance. Completing Corrective and Preventive Action (CAPA) projects and other Continuous Improvement (CI) projects as assigned, driving process enhancements and operational excellence. Controlling the incoming and outgoing documentation to the manufacturing department, ensuring accuracy, completeness, and compliance with regulatory requirements. Providing support to leadership during audits, including preparation, documentation review, and response to audit findings. Completing SAP transactions and reconciling materials and products in a timely and accurate manner, ensuring inventory accuracy and compliance with regulatory standards.

Requirements

Bachelors Degree in any discipline.
2+ years of experience in a GXP environment.
Strong attention to detail, analytical skills, and experience working in a fast-paced, regulated environment.
Excellent communication, problem-solving, and organizational skills.

Nice To Haves

Experience in data analysis, batch record review, deviation investigation, and CAPA project management.
Experience in controlling documentation, supporting audits, and completing SAP transactions.
Lean Six Sigma Green Belt certification.

Responsibilities

Collecting and analyzing data to identify trends, performance metrics, and areas for improvement within the manufacturing systems.
Reviewing batch records to support product release, ensuring accuracy, compliance, and adherence to quality standards.
Investigating and writing deviations, ensuring thorough documentation and timely resolution to maintain product quality and compliance.
Completing Corrective and Preventive Action (CAPA) projects and other Continuous Improvement (CI) projects as assigned, driving process enhancements and operational excellence.
Controlling the incoming and outgoing documentation to the manufacturing department, ensuring accuracy, completeness, and compliance with regulatory requirements.
Providing support to leadership during audits, including preparation, documentation review, and response to audit findings.
Completing SAP transactions and reconciling materials and products in a timely and accurate manner, ensuring inventory accuracy and compliance with regulatory standards.