Specialist, Operational Quality & Compliance

Requirements

• Bachelor's degree in genetics, molecular biology, biology, bioinformatics, or a related field; or equivalent experience within the organization.
• Prior experience in quality assurance, compliance, or operations support, preferably in a laboratory, manufacturing, or regulated environment.
• Familiarity with electronic quality management systems (EQMS).
• Working knowledge of ISO standards and quality system documentation practices.
• Strong attention to detail with effective organizational and recordkeeping skills.
• Ability to follow established procedures and meet deadlines consistently.
• Effective communication and interpersonal skills to work across teams and departments.
• Proficient in Microsoft Office applications (Word, Excel, Outlook).
• WHO IS NEOGEN:

Benefits

Additional Information

Come Be Part of a Mission that Matters! Hybrid Flexibility ESSENTIAL FUNCTIONS: Carries out day-to-day tasks related to operational quality and compliance to support operational goals and ensure alignment with established company standards. Helps operational teams complete Quality Events by providing support, guidance, and follow-up to ensure timely and thorough documentation and resolution. Reviews Quality Event records on a regular basis to confirm they are complete, accurate, and include appropriate corrective or preventive actions (CAPA). Works with scheduling and planning teams to help align production with quality requirements and ensure products are available to meet customer needs. Participates in troubleshooting efforts to identify root causes and help define clear, timely action steps for resolution. Supports the rollout and improvement of quality-related procedures, workflows, and response timelines, based on departmental priorities. Accurately enters, tracks, and maintains quality records in Q-Pulse and other quality management systems. Ensures quality management systems data is kept current and complete; follows up with responsible team members to close out open items within required timeframes. Assists with basic training to employees on quality processes, documentation procedures, and use of quality systems. Identifies and communicates process improvement opportunities to reduce errors, increase efficiency, and enhance quality and compliance. Works in collaboration with the Quality team to support ISO requirements, including document control, audit preparation, and corrective actions. Other duties as assigned by the manager.

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Company Intel

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