Quality Control Specialist

Quality Control Specialist

Join a dynamic and innovative team dedicated to excellence in cell and gene therapy at a brand new site. We are seeking a Quality Control Specialist who is eager to learn and contribute to our growing operations in a fast-paced environment.

Responsibilities

• Conduct ELISA based assays, Endotoxin, Flow Cytometry, and PCR analytical methods after receiving training.
• Support operations in both Newark and Princeton locations.
• Engage in quality inspection, materials management, and handling of reagents and live cells.
• Perform microbiological assays as part of team needs and adapt to evolving operational demands.
• Interact with clients and health authorities to ensure quality standards and regulatory compliance.

Essential Skills

• Master's degree with 1+ years of experience in the pharmaceutical industry or GMP environment, focusing on analytical methods or Quality Control, or a bachelor's degree with 2+ years of relevant experience.
• In-depth knowledge and hands-on experience with Flow Cytometry, PCR, ELISAs.
• Extensive QC experience with a comprehensive understanding of compendial methods and regulatory guidance.
• Ability to manage multiple priorities and work in a dynamic environment.
• Willingness to travel between facilities and work flexible hours.

Additional Skills & Qualifications

• Experience with LIMS, Endotoxin, Sterility, mycoplasma, and method qualification/validation.
• Familiarity with FDA, EMEA, ICH, USP, GMP guidelines, and cGMP regulations.
• Proven ability to support lab investigations, deviations, CAPAs, and change controls.
• Knowledge of Gene/Cell therapy products, particularly in clinical production.

Work Environment

Join a growing CDMO specializing in Cell/Gene Therapy at a brand new site. The role involves a dynamic work setting with opportunities to work with cutting-edge technologies and contribute to innovative projects in the field of cell-based product manufacturing.

Job Type & Location

This is a Contract to Hire position based out of NA, New Jersey.

Pay and Benefits

The pay range for this position is $25.00 - $35.00/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 Princeton, NJ.

Application Deadline

This position is anticipated to close on Oct 1, 2025.