Senior QC Potency Analyst: ELISA & Bioassay

Bora Biologics USA LLC; Rockville (MD); On-site; USD 88,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Paid time off

Professional development

Wellness program

Employee Assistance Program

Job summary

Bora Biologics USA LLC in Rockville, MD is seeking a QC Analyst to support analytical testing ensuring cGMP compliance, product release, and stability testing. You will guide and mentor lower level QC analysts and ensure accurate documentation and timely data review.

The role collaborates with Senior QC to develop and transfer testing methods, review data, and participate in CAPA investigations, with a focus on continuous improvement and quality assurance.

Qualifications

• Bachelor’s degree in a related field.
• Minimum 4 years of GMP QC experience.
• Knowledge of ELISA, bioassays, and cell culture.

Responsibilities

• Performs routine analytical testing including ELISA, bioassays, and cell culture for in-process, release, and stability samples.
• Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data to identify discrepancies and ensure SOP/GMP compliance.
• Identifies analytical data trends and reports findings to supervisors for review.

Skills

GMP knowledge

Data analysis

LIMS usage

Documentation

Education

Bachelor’s degree

Tools

ELISA

Cell culture

Bioassays

Job description

Bora Biologics USA LLC in Rockville, MD is seeking a QC Analyst to support analytical testing ensuring cGMP compliance, product release, and stability testing. You will guide and mentor lower level QC analysts and ensure accurate documentation and timely data review.

The role collaborates with Senior QC to develop and transfer testing methods, review data, and participate in CAPA investigations, with a focus on continuous improvement and quality assurance.