Job Title: QC Analytical Supervisor Location: Allendale, NJ Type: Contract To Hire Contractor Work Model: Onsite Hours: 2nd Shift, 2:30-11:00PM Responsibilities: + 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. + Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department. + Schedules and monitors daily operation of the 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. + Participate 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. + Ensure staff are recruited and selected using merit principles. + Ensure 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 the initiative to assess and develop supervisory competencies. + Other duties as assigned. Leadership Responsibility + Determines staffing needs and leads recruitment, interviewing, hiring, and onboarding of QC Analytical team members. + Provides day-to-day oversight in alignment with organizational policies, GMP regulations, and QC procedures. + Coaches, mentors, and develops staff; supports onboarding and drives career development planning and training opportunities. + Empowers team members by delegating responsibilities, setting clear expectations, and providing consistent feedback and accountability. + Fosters a culture of teamwork, collaboration, and problem-solving, addresses conflicts promptly and constructively. + Promotes a workplace culture aligned with the organization's mission, vision, and core values. + Leads performance management activities, including goal setting, performance reviews, and individual development planning. + Effectively communicates key information via team meetings, one-on-one discussions, and written communication. + Reviews QC data packages and records to ensure accuracy and compliance; prepares Certificates of Analysis for product release. + Represents the QC function in cross-functional meetings and external/internal audits as needed. Requirements: + 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. + Proficient with computer software with MS Office, iStability and LIMS. + 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. + Proficient with computer software with MS Office, iStability and LIMS. + Communicate effectively. + Supervises and manages performance. + Manages projects and functions. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M3- #LI- #DI- Ref: #558-Scientific System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.