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Quality Control Microbiology Supervisor

2 months ago

Allendale, New Jersey, United States Minaris Regenerative Medicine Full time
Job Overview

Position: Supervisor, QC Microbiology

Minaris Regenerative Medicine stands at the forefront of contract development and manufacturing, specializing in cell and gene therapy solutions. Our mission is to innovate and transform the landscape of medicine through collaborative efforts in the regenerative medicine sector.

Role Summary:

  • Oversee and guide personnel to fulfill cGMP obligations
  • Set key performance indicators and uphold quality assurance benchmarks
  • Supervise daily operations to ensure adherence to quality standards
  • Guarantee compliance with regulatory agency mandates
  • Conduct regular facility inspections and validate investigations
  • Propose enhancements for improved operational efficiency
  • Maintain a state of audit readiness within the team
  • Engage with both internal and external partners for accurate sampling and reporting

Required Qualifications:

  • Bachelor's degree in Microbiology or a related discipline
  • At least 7 years of experience in environmental monitoring or the biopharmaceutical sector
  • A minimum of 2 years in a leadership capacity
  • In-depth understanding of FDA and EU regulatory frameworks, with cGMP experience essential
  • Proficient in MS Office and LIMS software (experience with MODA is advantageous)

Key Competencies:

  • Demonstrates decisive action and sound judgment
  • Establishes and nurtures relationships with stakeholders
  • Communicates clearly and promotes ongoing improvement
  • Exhibits integrity and transparency
  • Effectively manages performance, projects, and operational functions

Supervisory Duties:

  • Determines staffing needs and provides guidance to team members
  • Mentors and develops staff for professional growth
  • Encourages teamwork and empowers employees
  • Leads through performance management and development initiatives

Direct Reports: QC Microbiology Analysts

Quality Assurance Commitment: Promotes a culture of quality and compliance with established standards