Pharma QC Analyst — Process Improvement & Compliance

Granules; Chantilly (VA); On-site; USD 70,000 - 98,000; Full time

Job summary

Granules seeks a Pharmaceutical Manufacturing QC Analyst to identify, develop, and implement improvement initiatives for manufacturing processes. You will work with manufacturing, QA/QC, and engineering to drive compliance and right-first-time practices.

You will support drug product manufacturing by ensuring cgmp compliance, adhering to SOPs, and delivering quality and efficiency improvements through hands-on operations and data analysis.

Qualifications

• Bachelor's degree in chemistry or pharmaceutical sciences, or 5+ years directly related experience.
• Knowledge of cGMP and FDA regulatory requirements.
• Hands-on experience in pharmaceutical manufacturing environments.

Responsibilities

• Interpret research, equipment, and operational data.
• Perform, evaluate, and analyze in process testing for quality of raw materials, in process materials, and finished products.
• Maintain and calibrate production and technical equipment.
• Inspect areas for compliance with sanitation standards.
• Create, review, and revise Master Batch Records and related documentation.
• Perform in-process audits to ensure compliance with regulations and instructions.
• Train and advise personnel in technical, scientific, and equipment procedures.
• Develop approaches and solve complex problems using new technologies or continuous improvement tools.
• Coordinate activities with suppliers, contractors, clients, or other departments.

Skills

cGMP compliance

FDA regulations

SOPs knowledge

Data analysis

QA/QC collaboration

Problem solving

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Job description

Granules seeks a Pharmaceutical Manufacturing QC Analyst to identify, develop, and implement improvement initiatives for manufacturing processes. You will work with manufacturing, QA/QC, and engineering to drive compliance and right-first-time practices.

You will support drug product manufacturing by ensuring cgmp compliance, adhering to SOPs, and delivering quality and efficiency improvements through hands-on operations and data analysis.