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Supervisor, QC Microbiology

Minaris
ALLENDALE, NJ Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 3/3/2025

Supervisor, QC Microbiology

At Minaris Regenerative Medicine, our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

Job Description

The Supervisor, QC Microbiology will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI's, while adhering to quality control-microbiological and technical standards. The QC Environmental Monitoring Supervisor will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.

Essential Functions and Responsibilities

  • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
  • Schedules and monitors daily operation of department based on projected client demands.
  • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
  • Approval of investigations and documentation of non-confirming events and environmental excursions.
  • Recommends process improvements to achieve greater efficiency within the department and between sites.
  • Participates in department and cross functional meetings.
  • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
  • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
  • Other duties as assigned.

Qualifications

  • Bachelor's degree in a Microbiology or relevant field
  • Minimum of 7 years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
  • Minimum of 2 years of experience in a supervisory or lead role.
  • Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
  • Strong knowledge of microbiological test methods and philosophies.
  • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
  • Proficient with computer software with MS Office and LIMS (MODA experience preferred).

Competencies/Candidate Profile

  • Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem solving, customer-centric, communication, project management, and presentation skills

Supervisory Responsibility

  • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
  • Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
  • Couches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
  • Empowers employees to take responsibility for their jobs and goals.
  • Delegates responsibility and holds staff accountable by providing regular feedback.
  • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
  • Create a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
  • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
  • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.

Quality Requirements

  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
  • Attend all required Quality & Compliance training at the specified interval.

Direct Reports

  • QC Microbiology Analysts

Required Training

  • GxP/GDP Training as assigned
  • EHS Safety Training
  • Aseptic Processing Standards

Working Environment

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully. An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.

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