Quality Control Analyst

Infotree Global Solutions; Frederick (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Infotree Global Solutions in Frederick, MD seeks a QC Analyst to support analytical testing and quality control activities in a biotechnology/pharmaceutical setting. The role emphasizes GMP compliance, lab documentation, and quality systems to ensure release testing and continuous improvement.

Responsibilities include performing analytical assays (Flow Cytometry, ELISA, qPCR), data review, SOP and protocol preparation, and participation in OOS investigations, deviations, and root-cause analysis.

Qualifications

• Bachelor’s degree (or higher) in biotech or related field with QA experience
• Knowledge of GMP, SOPs, and QC processes
• Experience with Flow Cytometry, ELISA, PCR/qPCR, or cell-based bioassays
• Familiarity with OOS investigations and root cause analysis

Responsibilities

• Perform analytical testing of raw materials, intermediates, and final products using techniques such as Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
• Review laboratory data, test records, and documentation to support in-process testing and drug substance and drug product release.
• Assist with laboratory instrument calibration, routine maintenance, and laboratory readiness.
• Prepare and revise SOPs, qualification and validation protocols, and reports.
• Support OOS investigations, deviations, and root cause analysis.
• Monitor compliance with GMP requirements, procedures, and quality systems.
• Review proposed changes to laboratory procedures, methods, and systems.
• Track laboratory metrics and support continuous improvement initiatives.
• Communicate testing updates and collaborate with scientific and technical teams.

Skills

GMP compliance

Analytical testing

Lab documentation

Quality control

Flow Cytometry

ELISA

qPCR

Cell-based assays

SOP development

OOS investigations

Root cause analysis

Deviation handling

Education

Bachelor’s degree in biotechnology or related field

Associate degree with QA experience

Job description

We are seeking a QC Analyst to support laboratory testing and quality control activities in a biotechnology or pharmaceutical environment. The ideal candidate will have experience with analytical testing, GMP compliance, laboratory documentation, and quality systems.

Key Responsibilities

• Perform analytical testing of raw materials, intermediates, and final products using techniques such as Flow Cytometry, ELISA, qPCR, and cell-based bioassays.
• Review laboratory data, test records, and documentation to support in-process testing and drug substance and drug product release.
• Assist with laboratory instrument calibration, routine maintenance, and laboratory readiness.
• Prepare and revise Standard Operating Procedures (SOPs), qualification and validation protocols, and reports.
• Support out-of-specification (OOS) investigations, deviations, and root cause analysis.
• Monitor compliance with GMP requirements, established procedures, and applicable quality systems.
• Review proposed changes to laboratory procedures, methods, and systems.
• Track laboratory metrics and support continuous improvement initiatives.
• Communicate testing updates and collaborate with scientific and technical teams.

Qualifications

• Bachelor’s degree; OR an associate degree with at least 2 years of relevant biotechnology or related industry experience, including Quality Control experience; OR a high school diploma with at least 3 years of relevant biotechnology or related industry experience, including Quality Control experience.
• Knowledge of GMP, SOPs, laboratory practices, and quality control processes.
• Experience with analytical techniques such as Flow Cytometry, ELISA, PCR/qPCR, or cell-based bioassays.
• Familiarity with OOS investigations, deviations, and root cause analysis.

Preferred Qualifications

• Experience in the biotechnology or pharmaceutical industry.
• Experience supporting analytical testing and biopharmaceutical product release.