QA Compliance Specialist - Audits and Supplier Quality

Corium Innovations; Grand Rapids (MI); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision

Flexible spending accounts

Life insurance

Disability insurance

Employee assistance program

Job summary

Corium Innovations seeks a Quality Assurance Compliance Specialist to support QA compliance across operations. You will perform cGMP audits, manage supplier quality, and lead investigations to ensure regulatory alignment.

The role requires strong attention to detail, knowledge of FDA guidelines, and effective communication with internal customers. A Bachelor’s degree is preferred, with Healthcare/Pharma exposure a plus.

Qualifications

• Knowledge of Quality Assurance principles and industry standards.
• Familiarity with FDA cGMP regulations and guidance documents.
• Ability to maintain accurate records and ensure regulatory compliance.
• Strong attention to detail and organizational skills.
• Excellent interpersonal communication and teamwork.

Responsibilities

• Provide QA compliance oversight to operational areas.
• Perform internal and supplier cGMP audits and regulatory audits.
• Manage Supplier Quality Management system.
• Lead investigations as needed (DEV, CA/PA) and participate in root-cause analysis.
• Serve as QA liaison to internal customers and stakeholders.
• Maintain the training system and ensure training completeness.

Skills

Quality Assurance

Regulatory compliance

cGMP knowledge

Documentation

Interpersonal skills

Attention to detail

Education

High School Diploma or GED

Bachelor’s Degree

Job description

Corium Innovations seeks a Quality Assurance Compliance Specialist to support QA compliance across operations. You will perform cGMP audits, manage supplier quality, and lead investigations to ensure regulatory alignment.

The role requires strong attention to detail, knowledge of FDA guidelines, and effective communication with internal customers. A Bachelor’s degree is preferred, with Healthcare/Pharma exposure a plus.