Onsite QA Lead: GMP/FDA Compliance

Granules Pharmaceuticals, Inc.; Manassas (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Granules Pharmaceuticals, Inc. in Manassas, VA is seeking a Quality Assurance leader responsible for ensuring GMP, FDA and SOP compliance across the facility.

The role oversees inspections of components, bulk and final products, release lead times, and training requirements to maintain site readiness. You will manage internal and external audits, support validation document reviews, and provide QA guidance for batch records, stability reports and annual product quality reviews, while mentoring

Qualifications

• Expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...)
• cGMP compliance within the pharmaceutical manufacturing industry
• Writing and maintaining cGMP documentation
• Analyze data/information and resolve complex issues
• Verbal and written communication skills
• Work and communicate with cross-functional teams
• Multiple priorities and re-prioritize tasks
• Strong computer skills and working knowledge of Microsoft Office Suite and Adobe
• Demonstrated ability to work on complex assignments in collaboration with various departments.

Skills

FDA guidance

cGMP compliance

cGMP documentation

Data analysis

Communication skills

Cross-functional teamwork

Prioritization

MS Office & Adobe

Collaboration

Education

Bachelor's degree in life sciences

Master’s degree in life sciences

Job description

Granules Pharmaceuticals, Inc. in Manassas, VA is seeking a Quality Assurance leader responsible for ensuring GMP, FDA and SOP compliance across the facility.

The role oversees inspections of components, bulk and final products, release lead times, and training requirements to maintain site readiness. You will manage internal and external audits, support validation document reviews, and provide QA guidance for batch records, stability reports and annual product quality reviews, while mentoring