The QC Laboratory Specialist supports the manufacture and release of products and incoming materials by performing routine quality control activities. This role requires a strong understanding of scientific principles, analytical methods, and GMP compliance to ensure data integrity and product quality.
Key Responsibilities:
Lead and execute testing following written methodologies, ensuring results are reported clearly and accurately, maintaining data integrity from the first attempt. Demonstrate a deep understanding of the scientific principles and method validation for the assays conducted.
Oversee and manage the utilization of chromatography technologies to conduct complex assays, ensuring proper calibration and maintenance of chromatography equipment for the highest accuracy in results.
Critically review and evaluate GMP assay data, providing comprehensive insights and effectively communicating findings to manufacturing teams for alignment and adherence to quality standards.
Execute and prioritize tasks with minimal supervision, demonstrating exceptional decision-making skills in complex situations and leading lab investigations to resolve issues.
Coordinate and schedule preventative maintenance activities with external vendors, ensuring all laboratory equipment is maintained in optimal condition and readiness.
Revise and enhance standard operating procedures as needed, supporting Process Owners and providing expertise to maintain and improve applicable methods.
Design and implement comprehensive training programs for team members on applicable procedures, ensuring consistency, compliance, and high performance within the team.
Serve as a subject matter expert on multiple methods/topics within the team, providing advanced knowledge and insights to drive innovation and excellence, and mentoring team members to foster professional growth.
Ensure compliance with current GMP regulations and quality systems, promoting a quality mindset throughout the department, and proactively identifying, escalating, and preventing safety issues.
Always maintain the area of responsibility in a state of inspection readiness, demonstrating proactive compliance with all regulatory requirements and performing other departmental duties as assigned by management.
Previous leadership experience

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