Quality Control Analyst

Global Life Science Hub; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Global Life Science Hub is establishing a state-of-the-art New Jersey facility and is hiring 5 QC Analysts to build the QC lab supporting commercial release testing. The role focuses on cGMP-compliant testing for raw materials, in-process samples, release, and stability programs.

The QC Analyst will help shape the lab, support first GMP commercial batches, and implement cutting-edge biologics testing technologies while collaborating with Manufacturing, MSAT, and QA teams.

Qualifications

• 2–8 years of experience in a cGMP QC laboratory.
• Hands-on experience with protein chemistry techniques (HPLC, SDS-PAGE, ELISA, capillary electrophoresis, cell-based assays).
• Experience authoring/revising SOPs, methods, or technical reports.

Responsibilities

• Execute analytical methods HPLC, SDS-PAGE, ELISA, capillary electrophoresis, cell-based assays; validate results.
• Review and document test results ensuring alignment with cGMP and ICH standards.
• Participate in investigations, OOS, deviations, CAPA with root cause analysis.
• Collaborate with cross-functional teams to support tech transfer and scale-up.
• Support internal/external audits and regulatory inspections.
• Contribute to continuous improvement of QC workflows and documentation.

Skills

cGMP QC lab experience

Protein chemistry techniques (HPLC,-SD

Education

Bachelor's degree in biotechnology/biochemistry/chemistry or related field

Tools

SOP writing

Job description

New Jersey | Biologics | QC Analyst II/III

Global Life Science Hub is partnered with a science-led biologics biotech as they launch a brand-new, state-of-the-art manufacturing facility in New Jersey. Alongside the commercial manufacturing team, the QC organization is being built from the ground up, and we’re hiring 5 QC Analysts at varying seniority levels to establish the laboratory that will underpin all commercial release testing.

With four cutting-edge manufacturing suites and planned scale-up to 6,000L capacity in the next 24–36 months, this site will serve as the engine room for biologics production with QC at the center of ensuring product quality, compliance, and patient safety.

As a QC Analyst, you’ll perform and review cGMP compliant testing to support raw materials, in-process samples, release, and stability programs. You’ll also have the rare opportunity to shape new QC labs, support the site’s first GMP commercial batches, and help implement the latest technologies in biologics testing.

Key Responsibilities

• Execute analytical methods HPLC, SDS-PAGE, ELISA, capillary electrophoresis, cell-based assays, compendial methods for clinical and commercial products.
• Review and document test results, ensuring alignment with cGMP and ICH standards.
• Participate in investigations, OOS, deviations, CAPA, including root cause analysis and closure.
• Collaborate with cross-functional teams, Manufacturing, MSAT, QA to support tech transfer and scale-up activities.
• Support internal/external audits and regulatory inspections.
• Contribute to continuous improvement of QC workflows, instrumentation, and documentation.

Qualifications

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field.
• 2–8 years’ experience in a cGMP QC laboratory
• Strong demonstrated hands-on experience in protein chemistry techniques (HPLC, SDS-PAGE, ELISA, capillary electrophoresis, cell-based assays).
• Previous experience authoring/revising SOPs, methods, or technical reports.

Please Note: These are full-time, on-site roles based in New Jersey.

Relocation assistance is available, and we welcome applications from candidates across the U.S. who are open to relocating.