Pharma QC Analyst: Quality & Compliance Champion

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 32,000 - 45,000; Full time

Job summary

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

The analyst will support manufacturing of drug products, ensuring compliance with cGMPs and SOPs, and will vary in scope based on products and strengths.

Qualifications

• Knowledge of cGMP and FDA regulatory requirements.
• Awareness of oral solid dosage products and ability to work hands-on.
• SOPs for processing equipment, rooms, manufacturing and QC areas.
• GMP compliance in a regulated work environment.
• Understanding of manufacturing processes and equipment procedures.

Responsibilities

• Interpret research, equipment, and operational data.
• Perform in-process testing for quality of materials, in-process materials, and finished products.
• Maintain and calibrate production and technical equipment.
• Inspect areas for sanitation compliance.
• Create, review, and revise Master Batch Records, SOPs, forms, and documentation.
• Perform in-process audits to ensure regulatory compliance and data accuracy.
• Train and advise personnel in technical procedures.
• Develop approaches to solve complex problems using new technologies and continuous improvement methods.
• Coordinate activities with suppliers, contractors, clients, or other departments.
• Advise and train others on new technologies.

Skills

cGMP knowledge

FDA regulation awareness

Hands-on pharma manufacturing

Documentation practices

Quality control understanding

Education

Bachelor's degree in chemistry/pharmaceutical sciences or related field

Job description

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

The analyst will support manufacturing of drug products, ensuring compliance with cGMPs and SOPs, and will vary in scope based on products and strengths.