QC Analyst II — GMP Analytical Testing & Data Integrity

Bora Biologics USA LLC; Rockville (MD); On-site; USD 74,000 - 87,000; Full time

Benefits offered by this job

Competitive salary and incentives

Comprehensive health coverage

Retirement plan with employer matching

Paid time off

Professional development

Wellness resources

Employee Assistance Program

Job summary

Bora Biologics USA, LLC is seeking a detail-oriented lab professional to support analytical testing programs in a cGMP environment. The role involves in-process, release, and stability testing, data entry, and ensuring adherence to SOPs and GMP standards.

Responsibilities include performing ELISA, Bioassays, and Cell Culture, reviewing data, and assisting with investigations to determine root causes. This position requires strong lab practices and collaboration with QA and cross-functional teams.

Qualifications

• Experience with ELISA, Bioassays, and Cell Culture in a regulated lab.
• Knowledge of GMP testing and laboratory quality systems.
• Familiarity with laboratory documentation practices and SOPs.
• Experience entering data into LIMS or comparable LIMS-like systems.

Responsibilities

• Performs routine analytical testing and more complex methods for product release and stability.
• Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data to ensure integrity and GMP compliance.
• Reports out-of-specification results and assists investigations into root causes.
• Maintains equipment and performs general lab housekeeping and reagent prep.
• Collaborates with QA to support quality records and SOP updates.

Skills

ELISA

Bioassays

Cell Culture

Quality Control

GMP testing

Good Laboratory Practices

Education

High School Diploma

Associate's degree in a scientific area

Bachelor's Degree in a scientific discipline

Job description

Bora Biologics USA, LLC is seeking a detail-oriented lab professional to support analytical testing programs in a cGMP environment. The role involves in-process, release, and stability testing, data entry, and ensuring adherence to SOPs and GMP standards.

Responsibilities include performing ELISA, Bioassays, and Cell Culture, reviewing data, and assisting with investigations to determine root causes. This position requires strong lab practices and collaboration with QA and cross-functional teams.