Quality Control Chemist - I

Unicon Pharma Inc; Frederick (MD); On-site; USD 55,000 - 75,000; Full time

Job summary

Unicon Pharma Inc. is seeking a QC Analyst to perform testing of raw materials, intermediates, and finished products using Flow Cytometry, ELISA, qPCR, and cell-based assays. The role includes data review, GMP documentation, and support for product release and CoAs.

You'll maintain instruments, write SOPs and validation protocols, and participate in investigations and deviations. A strong GMP background and MS Office skills are required.

Qualifications

• Bachelor’s degree or equivalent experience in biotechnology or related field.
• Experience with GMP documentation and product release is preferred.

Responsibilities

• Perform QC testing of materials and products using Flow Cytometry, ELISA, qPCR, and cell-based assays.
• Review and trend data, maintain GMP documentation, and support CoA issuance.
• Maintain lab instruments and perform calibration and routine maintenance.
• Write and revise SOPs, validation protocols, and reports.
• Assist with OOS investigations, deviations, and root cause analysis.
• Ensure GMP compliance and support continuous improvement.

Skills

GMP knowledge

SOPs

QC processes

OOS investigations

MS Office

Communication skills

Biotech/pharma experience

Flow Cytometry

ELISA

PCR/qPCR

Cell-based assays

Regulatory requirements

Education

Bachelor's degree

Associate degree + 2+ years experience

High school diploma + 3+ years experience

Job description

Note: First 7 weeks require Monday–Friday, 7:30 AM–4:00 PM for onboarding and training.

Key Responsibilities:

• Perform QC testing of raw materials, intermediates, and finished products using Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
• Review and trend test data, maintain GMP documentation, and support product release and Certificates of Analysis (CoAs).
• Maintain lab instruments, calibration, and routine maintenance.
• Write and revise SOPs, validation protocols, and reports.
• Support OOS investigations, deviations, and root cause analysis.
• Ensure GMP compliance, review procedural changes, and support continuous improvement.

Basic Qualifications:

• Bachelor’s degree; OR Associate degree with 2+ years of relevant biotechnology and QC experience; OR High school diploma with 3+ years of relevant experience.

Preferred Qualifications:

• Strong knowledge of GMP, SOPs, QC processes, and OOS investigations.
• Hands-on experience with Flow Cytometry, ELISA, PCR/qPCR, and cell-based assays.
• Knowledge of regulatory requirements (21 CFR Parts 11, 210, and 211).
• Proficiency in MS Office and strong communication skills.
• Preferred experience in the biotechnology or pharmaceutical industry.