Quality Assurance Operations Specialist - 3rd Shift

Corium Innovations • Grand Rapids, MI

4d

About The Position

Corium Innovations is seeking a Quality Assurance Operations Specialist to support Quality Assurance operations. The role provides quality oversight of manufacturing operations for commercial and development projects within a defined scope, applying technical, regulatory, and cGMP knowledge. The position works on the third shift, 10 p.m. to 6 a.m., Monday through Friday.

Requirements

• High school diploma or GED.
• Minimum of 2 years of related work experience; experience in an FDA-regulated industry is preferred.
• 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.
• Ability to work third-shift hours, 10 p.m. to 6 a.m., Monday through Friday.

Nice To Haves

• Bachelor’s degree in a science field preferred.
• Experience in an FDA-regulated industry preferred.

Responsibilities

• Apply technical, regulatory, and cGMP knowledge to provide quality oversight of manufacturing operations for commercial and development projects within a defined scope.
• Review executed manufacturing records for compliance with GDP and cGMP requirements.
• Review documentation and authorize the release of raw materials, work in process (WIP), and finished goods to the next processing stage.
• Provide on-the-floor quality support to Manufacturing, including event response, line-clearance support, record and logbook review, and verification of area and equipment cleaning.
• Serve as the first-line Quality contact for manufacturing events and quality issues, ensuring related documentation is complete and accurate.

Benefits

• Medical, dental, and vision benefits.
• Flexible spending accounts.
• Life insurance and 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
• Career Level: Mid Level
• Education Level: High school or GED