Quality Operations Analyst I

About the role

We are seeking a motivated Quality Operations Analyst I to support quality systems, master data governance, and quality operations within a regulated manufacturing environment. This role is ideal for early-career professionals looking to build expertise in quality systems, data management, compliance, and operational excellence within the biotechnology, pharmaceutical, or medical device industries.

Responsibilities

• Maintain quality-related master data and records across SAP, Teamcenter, MES, LIMS, and related systems.
• Process and support quality notifications, including NCRs, RMAs, RTVs, and investigation activities.
• Perform data validation, correction, remediation, and governance activities to ensure system accuracy and compliance.
• Troubleshoot SAP Quality Management (QM) transactional issues impacting manufacturing and quality operations.
• Support inspection planning, batch management, and quality inspection processing activities.
• Execute containment, disposition, and nonconforming material management activities.
• Aid in product lifecycle management (PLM) processes and system updates through Teamcenter.
• Support CAPAs, deviations, change controls, and quality investigations.
• Manage material master and product data updates in accordance with established procedures.
• Partner with Quality, Manufacturing, Supply Chain, Engineering, and Operations teams to maintain compliant and accurate system data.
• Ensure compliance with GMP requirements, quality standards, and internal operating procedures.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Supply Chain, Business, Operations, or a related field.
• 0-2 years of experience in Quality, Manufacturing, Operations, Supply Chain, or a related function within a regulated industry.
• Basic understanding of GMP, GDP, Quality Management Systems (QMS), and regulated manufacturing environments.
• Experience working with enterprise systems, databases, or master data management processes.
• Strong attention to detail and commitment to data accuracy.
• Excellent problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications, particularly Excel.

Preferred Qualifications

• Experience with SAP Quality Management (QM), Oracle, or other ERP platforms.
• Familiarity with Teamcenter, PLM, MES, or LIMS systems.
• Exposure to NCRs, CAPAs, deviations, investigations, or change control processes.
• Experience in medical device, biotechnology, pharmaceutical, or other highly regulated manufacturing environments.
• Understanding of master data governance and quality system administration.
• Exposure to Lean Manufacturing, Operational Excellence, or continuous improvement methodologies.