Job Title: Quality Control Associate I
Job Description

The Quality Control Associate I will perform various testing methods to develop and improve flow cytometry and other analytical methods. This role includes performing cell culture and counting, quality control analysis, and providing training and oversight to new team members.

ResponsibilitiesPerform accurate execution of all company and client test methods and procedures of cellular products to ensure safety and efficacy.Perform maintenance, monitoring, and troubleshooting of laboratory equipment.Test, document, and report results following CGMP and GTP guidelines.Organize the lab and maintain supplies in a neat manner.Perform cleanings of laboratory equipment per SOP.Assist in equipment and method qualification/validation activities.Cross-train in methods for multiple clients to increase efficiency.Upload data in real-time to shared drives or client SharePoint sites.Prepare reagents and media.Respond to equipment alarms using the Linc Alarm Report system.Troubleshoot malfunctioning equipment based on knowledge and experience.Investigate out-of-specification, out-of-trend, and non-conforming test results.Initiate, investigate, and prepare deviation reports with supervisor input.Implement corrective and preventive actions as needed.Document training and execute shipping test samples to contract laboratories.Complete all documentation according to SOPs, CGMP, and GDP.Communicate effectively with co-workers, departments, management, and clients.Assist in training other Quality Control technicians.Essential Skills1-2 years of experience performing flow cytometry assays and endotoxin testing.1-2 years of cell culture experience.Experience with test methodology within a quality control setting.Proficiency in microbiology testing and equipment usage.Bachelor's or Master's degree in a related scientific field.Experience in a CGMP/GTP environment.Additional Skills & QualificationsExperience with microbiology test methods.Experience training and leading others in a lab setting.Maintaining training records and coordinating with Document Control and Training groups.Managing materials and supplies.Ensuring timely issuance and review of Certificate of Analysis.Tracking and trending deviations, Change Controls, and CAPAs.Experience in cell count methodologies.Academic or industrial cell therapeutic experience.2-4 years of experience in a Quality Control laboratory or biopharmaceutical industry.Proficiency with Microsoft Office and Visio.Work Environment

The Quality Control Associate I will work within an aseptic environment as part of the Analytical Team. Shifts are Sunday-Thursday (6 am - 2:30 pm) and Tuesday-Saturday (6 am - 2:30 pm), with training from Monday to Friday (8 am - 4:30 pm). Flexibility is required as cell and gene therapy processes can be delayed. Morning shifts involve cleaning the lab, setting up equipment, and performing controls to ensure readiness for sample processing. All methods and SOPs are electronic-based, while testing and documentation are paper-based.

Pay and Benefits

The pay range for this position is $30.00 - $32.00

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 21, 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.