Senior QA Associate — GMP, CAPA & Compliance

Artech Information System LLC; Baltimore (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading IT staffing company is seeking a Senior QA Associate to ensure compliance with quality standards in the pharmaceutical sector. The role requires 8+ years of experience in Quality Assurance, including batch record review and deviation investigations. Strong interpersonal, communication, and organizational skills are essential. The candidate will work with minimal supervision to conduct compliance reviews and collaborate with production units. This is a critical position located in Baltimore, MD.

Qualifications

• 8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry.
• Demonstrated experience performing batch record review and disposition.
• In depth knowledge of CGMPs and Regulatory Guidelines.

Responsibilities

• Conduct compliance review of peer's work before management approval.
• Determine product compliance with manufacturing standards.
• Review executed commercial production records for GMP compliance.

Skills

Interpersonal skills

Communication skills

Organizational skills

Critical thinking

Attention to detail

Education

BS/BA or MS in Chemistry or closely related field

Job description

A leading IT staffing company is seeking a Senior QA Associate to ensure compliance with quality standards in the pharmaceutical sector. The role requires 8+ years of experience in Quality Assurance, including batch record review and deviation investigations. Strong interpersonal, communication, and organizational skills are essential. The candidate will work with minimal supervision to conduct compliance reviews and collaborate with production units. This is a critical position located in Baltimore, MD.