2nd-Shift QC Analytical Associate II (Cell Therapy)

Katalyst CRO; Allendale (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Quality Control Analytical Associate II to support clinical and commercial production on the 2nd shift (2:30 PM–11:00 PM). You will assist with analytical testing, data acquisition, and CAPA activities, ensuring cGMP compliance and high data integrity across multiple client projects.

The role requires a Bachelor's in a scientific field and at least 2 years in QC labs. Experience with flow cytometry, CBC, and ELISA is a plus; strong documentation and cross-team

Qualifications

• Bachelor's degree in a scientific discipline required.
• Minimum 2 years in QC laboratory or biopharmaceutical setting preferred.
• Experience with flow cytometry and CBC assays is a plus.
• Experience in cGMP/GTP-regulated environments preferred.

Responsibilities

• Support process checkpoints, stability, in-process and release analytical testing.
• Maintain and troubleshoot laboratory equipment; perform maintenance per SOPs.
• Document results and ensure compliance with cGMP and GDP.
• Prepare deviation reports and participate in CAPA activities.
• Cross-train on methods and support audits/inspections.

Skills

Cell count

Viability testing

ELISA

Flow cytometry

Endotoxin testing

CBC

cGMP knowledge

Microsoft Office

Visio

LIMS

Data documentation

CAPA implementation

Verbal and written communication

Team collaboration

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

MS Office

Visio

Job description

Katalyst CRO is seeking a Quality Control Analytical Associate II to support clinical and commercial production on the 2nd shift (2:30 PM–11:00 PM). You will assist with analytical testing, data acquisition, and CAPA activities, ensuring cGMP compliance and high data integrity across multiple client projects.

The role requires a Bachelor's in a scientific field and at least 2 years in QC labs. Experience with flow cytometry, CBC, and ELISA is a plus; strong documentation and cross-team