QC Associate II

Actalent • Allendale, NJ • 1d ago

Job Title: Quality Control Associate II

Job Description

Join our dynamic team as a Quality Control Associate II, where you will contribute to developing and analyzing flow cytometry methods, as well as ensuring the quality control of cell cultures. You will play a pivotal role in improving laboratory workflows and training new employees, while executing tests and maintaining equipment to ensure the safety and efficacy of cellular products.

Responsibilities

Perform testing to develop and analyze flow cytometry methods.

Conduct cell culture and cell counting for quality control analysis.

Provide input to enhance laboratory workflow and activities.

Offer training and oversight to new team members.

Execute company and client test methods and procedures for cellular products.

Maintain and troubleshoot laboratory equipment, including routine start-ups and shutdowns.

Document and report test results in accordance with CGMP and GTP guidelines.

Perform client proficiency testing under supervision.

Organize the lab and manage supplies efficiently.

Clean laboratory equipment according to SOPs.

Assist in equipment and method qualification and validation activities.

Cross-train in methods for multiple clients to enhance lab efficiency.

Upload data in real-time to shared drives or client SharePoint sites.

Essential Skills

3-4 years of experience with flow cytometry assays and endotoxin testing.

3-4 years of experience with cell culture.

Experience in a quality control setting.

Bachelor's or master's degree in a related scientific field.

Proficiency in microbiology testing and equipment use.

Experience in CGMP/GTP environments.

Experience in cell count methodologies.

Prior experience in cell therapeutic environments.

Additional Skills & Qualifications

Experience in clinical laboratory, microbiology, hematology, blood banking, or immunology.

Experience with computer software such as Microsoft Office and Visio.

Ability to manage training records and coordinate with Document Control and Training groups.

Experience in managing materials and supplies.

Expertise in compliance requirements for maintaining an inspection-ready laboratory state.

Participation as a subject matter expert during audits and inspections.

Work Environment

The work environment includes a flexible schedule with two shifts: 2nd Shift, Sunday-Thursday (2:30 PM-11:00 PM) and 1st Shift, Sunday-Thursday (6:00 AM-2:30 PM). Initial training occurs Monday-Friday from 8:00 AM-4:30 PM for the first 2-3 months. You will work within an aseptic quality environment, collaborating with scientists and other associates to move methods forward. The role requires flexibility to accommodate potential delays in cell and gene therapy processes.

Pay and Benefits

The pay range for this position is $36.00 - $38.00/hr.

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 is anticipated to close on Sep 16, 2025.

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