Senior Potency QC Analyst

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

Benefits offered by this job

Competitive salary incentives

Health coverage

Retirement savings plans

Paid time off

Professional development opportunities

Employee wellness programs

Employee Assistance Program

Job summary

Bora Biologics is seeking a QC Analyst to support analytical testing programs to ensure cGMP compliance in in-process, release and stability testing. You will guide and partner with lower level QC analysts, ensure accurate documentation, and timely review of data while following SOPs.

The role involves performing ELISA, bioassays, and cell culture, along with basic methods, data entry in LIMS, and contributing to SOP updates and training.

Qualifications

• Bachelor's degree required.
• Minimum 4 years of experience in GMP/GLP-biotech pharma environments.
• Experience with ELISA, bioassays and cell culture preferred.
• Strong organization and ability to work independently in a fast-paced setting.

Responsibilities

• Perform routine analytical testing (ELISA, bioassays, cell culture) and basic methods (pH, conductivity, osmolality) per SOPs.
• Peer-review test data; identify deviations and trends for supervisor review.
• Investigate out-of-spec results and initiate CAPA/Quality event records.
• Update and develop SOPs; train junior analysts on methods.
• Oversee equipment calibration and maintenance; assist in troubleshooting.

Skills

GMP knowledge

Good Laboratory Practices

Mentoring

Analytical testing

Education

Bachelor's Degree

Job description

Bora Biologics is seeking a QC Analyst to support analytical testing programs to ensure cGMP compliance in in-process, release and stability testing. You will guide and partner with lower level QC analysts, ensure accurate documentation, and timely review of data while following SOPs.

The role involves performing ELISA, bioassays, and cell culture, along with basic methods, data entry in LIMS, and contributing to SOP updates and training.