Senior Quality Control Inspector

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Supports QC collaboration with Quality Management to ensure all quality standards are met, including but not limited to inspecting reports are properly updated and completed in a timely manner.
• Inspects products, processes, and systems to ensure compliance with quality standards.
• Affords assistance in investigating non-conformances, identifying root causes, and implementing corrective actions.
• Supports documentation and reporting quality control findings and the analysis of data to recommend process improvements.
• Serves as a key technical resource within the Quality Control organization, providing support for incoming material inspection, batch record review, product release activities, non-conformance investigations, and continuous improvement initiatives.
• Works collaboratively with Manufacturing, Engineering, Quality Assurance, Supply Chain, and other cross-functional groups to support daily operations and maintain operational efficiency.
• Supports Review & Release activities including review of manufacturing, inspection, and quality records to ensure completeness, accuracy, and compliance with established procedures.
• Supports Inspection and testing raw materials, intermediates and record test results.
• Affords assistance in test method validation, implementation, and execution.
• Affords assistance in training employees in quality standards, KPIs and procedures.
• Affords assistance in the implementation of new or improved quality control systems as needed.
• Maintains work areas and equipment in a clean and orderly condition.
• Must be able to work in a Team environment, multi-task and communicate effectively.
• Demonstrate excellent organizational and time management skills.

Qualifications

• High school diploma or equivalent with 5 years of experience; A bachelor’s degree or associate degree in a related field is preferred.
• Related work experience is preferred in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry.
• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
• Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
• Knowledge of QC terms, tools, and methodologies.
• Working knowledge of standard laboratory practices and safety.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
• Detail-oriented.