Senior Quality Control Specialist — Cell Therapy

Regulatory Jobs; Florham Park (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Celularity Inc. is seeking a Sr. Specialist, Quality Control to support routine product testing, visual inspection and retention/sample oversight for clinical and commercial products.

The role interfaces with multiple groups, performs tasks independently, interprets results and supports audits as a QC SME when needed. Responsibilities include testing, documentation, troubleshooting, disposition support, CoA generation, OOS/OOT investigations, equipment qualification, sampling, and participation

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum of 5+ years of quality control/analytical experience in a cGMP-regulated environment.
• Ability to understand, follow, interpret and apply good laboratory practices.
• Strong organizational and time management skills.
• Independent and team-player with excellent communication and attention to detail.

Responsibilities

• Perform routine testing of cellular, tissue, in-process and final product samples per approved methods.
• Record testing activities and results in controlled documents or electronic systems.
• Assist with assay and equipment troubleshooting, cleaning and maintenance.
• Support disposition activities ensuring testing is completed on time.
• Generate and review Certificates of Analysis for product release readiness.
• Initiate investigations for deviations and OOS/OOT results.
• Support equipment calibration and qualification activities.
• Assist with analytical method transfers and training/qualification.
• Coordinate testing and inspection of incoming raw materials and components.
• Collect, prepare and ship samples to external labs; file results timely.
• Perform visual inspection of cellular/tissue products for quality attributes.
• Support environmental monitoring in cGMP manufacturing.
• Participate in internal audits, regulatory inspections and 3rd party audits.

Skills

Quality control

Analytical testing

cGMP

Documentation

Audits

Education

Bachelor’s degree in a scientific discipline

Job description

Celularity Inc. is seeking a Sr. Specialist, Quality Control to support routine product testing, visual inspection and retention/sample oversight for clinical and commercial products.

The role interfaces with multiple groups, performs tasks independently, interprets results and supports audits as a QC SME when needed. Responsibilities include testing, documentation, troubleshooting, disposition support, CoA generation, OOS/OOT investigations, equipment qualification, sampling, and participation