Specialist, Operational Quality & Compliance

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.

PREFERRED QUALIFICATIONS

• 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.
• Able 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).