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.
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.
- 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.
Quality Requirements
- 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.
Direct Reports
- QC Microbiology Analysts
Requirements:
- 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.
#J-18808-Ljbffr
