QC Micro Lab Supervisor - System One Holdings, LLC : Job Details

Title:Supervisor, QC Microbiology Location:Mahwah, NJ Schedule:2nd Shift Wednesday through Saturday 3:30 PM to 2 AM or Sunday through Wednesday 3:30 PM to 2 AM Type:Direct Hire Responsibilities: 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.

• 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.

• 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.
• Coaches, 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.
• Creates 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.

• Build Quality into all aspects of your work by maintaining compliance to all 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.

• QC Microbiology Analysts

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