Description Perform testing to help develop methods for flow cytometry and QC analysis • 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 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. • Acts decisively • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze, and resolve problems effectively. • Builds and maintains relationships • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders. • Communicates effectively. • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback. • Fosters continuous improvement and innovation. • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically. • Supervises and manages performance. • Manages projects and functions. • 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. Skills flow cytometry, cell culture, aseptic, Cgmp, Assay, Document control, microbiology, tissue culture, tissue samples, quantitative analysis, gmp, clinical laboratory, Quality control, Bioburden, pcr, Qc Top Skills Details flow cytometry,cell culture,aseptic,Cgmp,Assay,Document control Additional Skills & Qualifications Bachelors or masters degree in related scientific field Experience with microbiology test methods Experience and proficiency with microbiology testing and use of necessary equipment Experience helping to train and lead others while in the lab • 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 and LIMS. • QC Analysts (Approximately 8-10 reports) Experience Level Expert Level Pay and Benefits The pay range for this position is $42.00 - $51.59 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position will be accepting applications until Jan 10, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.