Job Title: QC Analytical Specialist
Job Description

Perform testing to help develop methods for flow cytometry and QC analysis. Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department. Schedule and monitor daily operations based on projected client demands. Conduct routine walkthroughs of the facility to ensure compliance with regulatory and quality practices. Approve investigations and documentation of non-conforming events and out-of-specification results. Recommend process improvements to achieve greater efficiency within the department and between sites. Participate in department and cross-functional meetings. Maintain audit readiness by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness. Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns. Manage projects and lead initiatives in the workplace, organizing resources, people, and activities to ensure collaboration and the achievement of project and function goals. Build and manage a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensure tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements, holding staff accountable for meeting expectations. Train and develop staff, provide constructive performance feedback and appraisals, and take appropriate corrective action to address performance and conduct issues. Promote efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identify and implement improvements and innovations that increase efficiency and enhance work quality. Promote ongoing development of staff and take initiative to assess and self-develop supervisory competencies. Act decisively, exercise good judgment, and make effective, sound, timely, and informed decisions. Build and maintain relationships, communicate effectively, and foster continuous improvement and innovation. Supervise and manage performance, manage projects and functions, determine staffing levels, recruit, interview, select, hire, and employ appropriate numbers of employees. Provide oversight and direction to employees in accordance with the organization's policies and procedures. Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities. Empower employees to take responsibility for their jobs and goals. Delegate responsibility and hold staff accountable by providing regular feedback. Foster teamwork and cohesiveness among department members; expeditiously initiate conflict resolution when issues arise. Create a workplace culture consistent with the mission, vision, guiding principles, and values of the organization. Lead employees using a performance management and development process that includes goal setting, feedback, and performance development planning. Appropriately communicate organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.

ResponsibilitiesPerform testing to help develop methods for flow cytometry and QC analysis.Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.Schedule and monitor daily operations based on projected client demands.Conduct routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.Approve investigations and documentation of non-conforming events and out-of-specification results.Recommend process improvements to achieve greater efficiency within the department and between sites.Participate in department and cross-functional meetings.Maintain audit readiness by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.Manage projects and lead initiatives in the workplace, organizing resources, people, and activities to ensure collaboration and the achievement of project and function goals.Build and manage a multi-sector workforce based on organizational goals, budget considerations, and staffing needs.Ensure tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements, holding staff accountable for meeting expectations.Train and develop staff, provide constructive performance feedback and appraisals, and take appropriate corrective action to address performance and conduct issues.Promote efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation.Identify and implement improvements and innovations that increase efficiency and enhance work quality.Promote ongoing development of staff and take initiative to assess and self-develop supervisory competencies.Act decisively, exercise good judgment, and make effective, sound, timely, and informed decisions.Build and maintain relationships, communicate effectively, and foster continuous improvement and innovation.Supervise and manage performance, manage projects and functions, determine staffing levels, recruit, interview, select, hire, and employ appropriate numbers of employees.Provide oversight and direction to employees in accordance with the organization's policies and procedures.Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.Empower employees to take responsibility for their jobs and goals.Delegate responsibility and hold staff accountable by providing regular feedback.Foster teamwork and cohesiveness among department members; expeditiously initiate conflict resolution when issues arise.Create a workplace culture consistent with the mission, vision, guiding principles, and values of the organization.Lead employees using a performance management and development process that includes goal setting, feedback, and performance development planning.Appropriately communicate organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.Essential SkillsFlow cytometryCell cultureAseptic techniquesAssay developmentDocument control5-7 years of experience in GMPSupervisory experienceMicrobiologyTissue cultureQuantitative analysisClinical laboratory experienceQuality controlBioburden testingPCRStrong knowledge of FDA and EU regulatory standardsProficient with computer software including MS Office and LIMSAdditional Skills & QualificationsBachelor’s or master’s degree in a related scientific fieldExperience with microbiology test methodsProficiency with microbiology testing and necessary equipmentExperience helping to train and lead others in the labMinimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industryStrong knowledge of analytical test methods and philosophiesStrong knowledge of quality systems and ability to interpret quality standards of implementation and reviewQC Analysts (Approximately 8-10 reports)Work Environment

Shift: Tuesday to Saturday 6am-2:30pm. This person will be a part of the QC Analytical Team and will work alongside the QC Scientists and QC Associate III to move methods forward. They will work within an aseptic quality environment. While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions. Other exposures may include gases (nitrogen), corrosive chemicals (Clorox, potassium hydroxide), or liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating includes open space, cubicles, and office space with a moderate noise level. The employee must comply with the company's personal hygiene standards for aseptic processing and complete sterile gowning training/qualification. Testing and documentation are paper-based. Morning shift cleans the lab, sets up equipment, and performs controls for immediate sample testing. All methods and SOPs are electronic-based. Flexible schedule required due to potential delays in sample processing for cell and gene therapy.

Pay and Benefits

The pay range for this position is $42.00 - $52.00

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 24, 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 for other accommodation options.