Quality Assurance Specialist

Binding Minds Inc. (Certified Disability Owned Business Enterprise); Boston (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Binding Minds Inc. is seeking a quality professional in Boston with over 4 years of GMP experience in the pharmaceutical industry. The role involves quality oversight of external manufacturing and testing activities for clinical-stage products, requiring strong knowledge of GxP documentation and regulatory compliance.

Ideal candidates possess a bachelor's degree in a scientific discipline and proficiency with quality systems. Excellent communication and organizational skills are essential for this position.

Qualifications

• 4+ years of GMP experience in the pharmaceutical/biopharmaceutical industry.
• Strong knowledge of GxP documentation and regulatory requirements.
• Proficiency with quality systems.

Responsibilities

• Review batch records and analytical testing documentation.
• Support quality oversight of external manufacturing and testing activities.
• Assist with regulatory submissions and batch disposition.

Skills

GxP documentation

Regulatory requirements

Quality systems compliance

Communication skills

Organizational skills

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office applications

Job description

Seeking a quality professional with 4+ years of GMP experience in the pharmaceutical/biopharmaceutical industry to support quality oversight of external manufacturing and testing activities for clinical-stage products. Responsibilities include reviewing batch records, analytical testing documentation, regulatory submissions, source data verification, and supporting batch disposition and quality systems compliance.

The role requires strong knowledge of GxP documentation, regulatory requirements, quality systems, and cross-functional collaboration, along with excellent communication and organizational skills. A bachelor's degree in a scientific discipline and proficiency with quality systems and Microsoft Office applications are preferred.