QC Analytical Supervisor - System One Holdings, LLC : Job Details

Title:QC Analytical Supervisor Location:Mahwah, NJ area Schedule:Tues- Saturday 6 AM- 2:30 PM Type:Direct Hire Responsibilities: The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI's, while adhering to quality control and technical standards. This role will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance. This Supervisor will lead Quality staff members across various shifts.Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

• Schedules, plans, staffing, 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 OOS.
• 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.
• Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
• Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
• Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.
• Other duties as assigned.
• Supervises and manages performance.
• Manages projects and functions.
• Flexible and able to adapt to company growth and evolving responsibilities.
• 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.

• Bachelor's degree in Science or relevant field; Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.
• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
• Strong knowledge of analytical test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Understanding of quality system applications, including the training, deviations, CAPA management, etc.
• Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.).
• Experience participating in health authority inspections and/or client audits.
• Proficient with computer software with MS Office and LIMS.
• GxP/GDP Training