Senior QC Analyst – Analytical Separations

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

Benefits offered by this job

Health insurance

Retirement plan with employer matching

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Biologics USA, LLC seeks a detail-oriented analytical technician to support developmental and GMP testing programs. The role focuses on in-process, release, and stability testing with methods such as HPLC, CE, icIEF, and subvisible particle analysis.

The candidate will enter data into LIMS, review results, and help with investigations, deviations, and CAPAs while maintaining adherence to SOPs and cGMP requirements.

Qualifications

• Bachelor's degree in a scientific discipline with related experience.
• Associate's degree in a scientific area with related experience.
• High School Diploma with multiple years of analytical testing experience.
• Experience with HPLC, CE, icIEF, Subvisible Particle analysis, UV absorbance, pH, conductivity, osmolality, GMP testing, and GLP.
• Strong knowledge of cGMP and laboratory practices.

Responsibilities

• Perform routine analytical testing for in-process, release, and stability samples.
• Enter data into LIMS and review data for integrity.
• Assist with investigations and CAPAs as needed.
• Maintain equipment and perform routine lab cleaning and calibration.
• Revise SOPs and participate in special projects as required.

Skills

Analytical testing experience

LIMS data entry

GMP knowledge

HPLC

CE

icIEF

Subvisible particle analysis

pH measurement

Osmolality testing

Quality control

Education

Bachelor's Degree in a scientific discipline

Associate's degree in a scientific area

High School Diploma

Tools

LIMS software

Job description

Bora Biologics USA, LLC seeks a detail-oriented analytical technician to support developmental and GMP testing programs. The role focuses on in-process, release, and stability testing with methods such as HPLC, CE, icIEF, and subvisible particle analysis.

The candidate will enter data into LIMS, review results, and help with investigations, deviations, and CAPAs while maintaining adherence to SOPs and cGMP requirements.