Quality Assurance Specialist

Responsibilities

• Lead and participate as a team member in investigations (DEV, CA/PA).
• Review executed operations records; identify and report errors or omissions.
• Review documentation and release raw materials, WIP, and finished goods to next processing stage.
• Provide troubleshooting and guidance to manufacturing shop floor employees on quality issues.
• Serve as a Quality Assurance liaison to internal and external customers for development and commercial products.
• Receive and execute customer complaint investigations.

Requirements

• Bachelor’s Degree, preferably in a science or technical field.
• Minimum of 5 years of related work experience.
• Comprehensive knowledge of Quality Assurance principles, FDA cGMP regulations, FDA guidance documents, and/or regulatory submission requirements.
• Able to maintain accurate records.
• Strong attention to detail.
• Great interpersonal skills.

Qualifications

Corium Innovations is seeking a Quality Assurance Specialist II to provide oversight to manufacturing operations for both commercial and development projects using technical, regulatory, and cGMP knowledge. This is a unique opportunity to take on a key role with a broad range of responsibilities.

Skills

Not specified.

Benefits

• Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
• 401(k) retirement savings account with a company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.

Pay

TBD

Schedule

TBD