Quality Manager

BioTechne   •  

Wallingford, CT

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 54 days ago

Description

By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Description

The Wallingford site, part of Analytical Solutions Division of Bio-Techne, is seeking a Quality Manager. Reporting to the Director of Quality, this person will be a champion for Simple Plex consumables quality. Supports development and production teams during Assay transfer from Validation onward. Supports ISO 9001 Quality Management System compliance activities; responsible for day-to-day QA/QC for the Simple Plex consumables production, and provides on-going support to continuously improve the quality processes at this site.

Key Responsibilities

  • QA/QC Compliance with ISO 9001 QMS requirements
  • Manage a team of QA Analysts (Production Work Order analysis and assessment);
  • Participate in the development and ongoing maintenance of the quality manual and quality department SOPs
  • Conduct ongoing training and/or effectively communicate appropriate materials, as needed, in order to enhance QA Analysts knowledge
  • Participate and support Material Review Board activities; Simple Plex Change Control board; Corrective Action teams, and provide Quality representation on special projects
  • Perform Internal Audits as per ISO 9001.

Qualifications

Education and Experience

  • Bachelor's degree (minimum) in a scientific discipline, business or engineering with 5+ years of related experience
  • ISO 9001 experience and/or ISO 13485 is a plus
  • Strong leadership skills, with a proven ability to influence processes and outcomes in a highly cross-functional organization. Must be able to lead cross-functional teams to investigate complex issues and drive prioritized action(s) while employing risk-based, data driven thinking.
  • Expert in analysis of data. Must be able to analyze production data and assess metrics.
  • Solid understanding of the Plan/Do/Check/Act (PDCA) cycle.
  • Strong presentation skills.
  • Excellent computer skills and strong proficiency in MS Office.
  • Experience developing, reviewing, deploying Standard Work (WI's, MI's, SOPs)
  • Experienced with Life Science / Manufacturing is preferred
  • Good working knowledge of operational and quality processes in Life Sciences