Quality Assurance Lead

2 weeks ago

Farmingdale, New York, United States Enzo Biochem Inc. Full time
Job Overview

The Quality Assurance Manager plays a pivotal role in steering the quality assurance initiatives within the organization, ensuring adherence to global quality standards and fostering continuous enhancement in processes. This role encompasses the management of the quality oversight program, ensuring compliance with current Good Manufacturing Practices (cGMP) and various federal and international regulations.

Key Responsibilities:

  • Develop and uphold a comprehensive Risk Management Program aimed at guaranteeing high-quality laboratory testing, utilizing Quality Management Systems tools such as root-cause analysis and Corrective and Preventive Actions (CAPA).
  • Oversee Quality Assurance operations while upholding the Company’s Quality Standards.
  • Enhance the Quality Program through the integration of compliance software, facilitating components of the Quality Management System, including competency assessments, training, equipment management, environmental monitoring, and audit management.
  • Serve as the Subject Matter Expert on GMP Manufacturing, ISO 9000 & 13485, and Regulatory Affairs, with experience in Clinical In Vitro Diagnostics (CeIVD) considered an asset.

Specific Duties:

  • Design and maintain a Risk Management Program via Master Control to detect, document, investigate, analyze, and resolve all non-conformities across laboratory processes.
  • Manage daily operations in accordance with Good Manufacturing Practices (GMP), engaging in continuous improvement processes through data analysis and identification of enhancement opportunities.
  • Review process metrics and audit quality indicators for both laboratory (CAPA) and manufacturing GMP operations.
  • Conduct routine internal audits within the department, including off-site locations.
  • Assist external auditors from regulatory bodies, addressing any corrective actions as necessary.
  • Communicate findings to management and ensure compliance among staff.

Qualifications:

Education: A Bachelor’s degree in Medical Technology or a related field is required. A New York State Clinical Laboratory Technologist license is preferred. ASQ certification or equivalent is advantageous.

Experience: A minimum of five years in Quality Assurance is essential; a background in Lean methodologies and process improvement is preferred. Experience with GMP and ISO standards is required, with CeIVD experience being a plus.

Skills: Must be self-directed and capable of working independently; exhibits strong competencies in planning, problem analysis, judgment, decision-making, attention to detail, and possesses excellent written and verbal communication skills. Proficiency in Microsoft Office applications is essential.

If you are interested, we look forward to receiving your application.

Home - Enzo

The salary range estimated for this position based in New York is $ to $90,000.

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