Quality Assurance Compliance Specialist

Corium Innovations • Grand Rapids, MI

6h

About The Position

Corium Innovations is seeking a Quality Assurance Compliance Specialist to support Quality Assurance compliance. The role provides compliance oversight to operational areas using technical, regulatory, and cGMP knowledge. The specialist performs internal, supplier, and DEA compliance audits; manages the Supplier Quality Management system; leads and participates in investigations; serves as a Quality Assurance liaison to internal customers; and maintains the training system.

Requirements

• High school diploma or GED.
• Comprehensive knowledge of Quality Assurance principles, FDA cGMP regulations, FDA guidance documents, and/or regulatory submission requirements.
• Ability to maintain accurate records.
• Strong attention to detail.
• Great interpersonal skills.

Nice To Haves

• Bachelor’s degree preferred.
• Minimum of 2 years of related work experience preferred.

Responsibilities

• Provide compliance oversight to operational areas using technical, regulatory, and cGMP knowledge.
• Perform internal and supplier cGMP compliance audits and DEA compliance audits.
• Manage the Supplier Quality Management system.
• Lead and participate as a team member in investigations (DEV, CA/PA).
• Serve as the Quality Assurance liaison to internal customers.
• Maintain the training system.

Benefits

• Medical, dental, and vision coverage.
• Flexible spending accounts.
• Life insurance.
• Disability insurance.
• Employee assistance program.
• 401(k) retirement savings account with company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan.
• Approximately one additional week of paid time off for the annual holiday shutdown.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED