Senior Quality Specialist
About The Position
As a Senior Quality Specialist, you will play a key role in ensuring product quality, regulatory compliance, and operational excellence across manufacturing operations. You will support batch release activities, quality record management, product quality evaluations, and quality systems processes while partnering closely with Operations, Engineering, Supply Chain, and Commercial teams. In this position, you will help drive compliance with quality standards, support audit readiness, and contribute to continuous improvement initiatives that ensure the consistent delivery of high-quality products to our customers.
Requirements
- Bachelor's degree in Business, Engineering, Science, or another technical discipline.
- 5-10 years of experience in Quality Assurance, Quality Operations, or a related quality function.
- Strong knowledge of quality systems, batch record review, product release, and quality documentation processes.
- Proficiency with Microsoft Office applications.
- Experience using SAP and/or Manufacturing Execution Systems (MES).
- Experience utilizing quality data analysis and trending tools to support problem-solving and continuous improvement.
- Strong verbal and written communication skills.
- Ability to work independently in a fast-paced manufacturing environment.
Responsibilities
- Perform batch record review, compliance verification, and product release activities to support business objectives and ensure adherence to quality requirements.
- Maintain and manage quality records, batch documentation, retained samples, and archival processes in accordance with quality system and regulatory requirements.
- Evaluate product quality by assessing physical, manufacturing, and printing defects and performing quality inspections and testing activities.
- Analyze defect and quality performance trends, support investigations, and drive continuous improvement initiatives to improve product quality and manufacturing yield.
- Coordinate quality oversight activities for non-conforming or out-of-specification materials, ensuring appropriate segregation, documentation, and disposition.
- Support customer audits, health authority inspections, and internal audits by providing quality documentation, compliance information, and audit support.
- Maintain SAP master data and support quality management systems to ensure accurate and compliant quality records and processes.
- Collaborate with cross-functional teams to support quality objectives, compliance initiatives, and operational excellence programs within a GMP manufacturing environment.
Benefits
- equal employment opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
