Quality Control Microbiology Supervisor

2 weeks 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 revolutionize the medical landscape and achieve extraordinary outcomes within the regenerative medicine sector.

Position Summary:

  • Oversee and guide personnel to fulfill cGMP standards
  • Set and monitor Key Performance Indicators (KPIs) while upholding quality assurance protocols
  • Supervise daily operations to ensure quality adherence
  • Guarantee compliance with the requirements of regulatory bodies
  • Perform regular facility inspections and validate investigations
  • Suggest enhancements to processes for improved efficiency
  • Maintain readiness for audits within the department
  • Collaborate with both internal and external stakeholders 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 supervisory capacity
  • Comprehensive understanding of FDA and EU regulatory frameworks, with cGMP experience essential
  • Proficient in MS Office and LIMS software (experience with MODA is a plus)

Candidate Competencies:

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

Supervisory Duties:

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

Direct Reports: QC Microbiology Analysts

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



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