Quality Assurance Compliance Specialist

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

Due to our continued growth, Corium Innovations is seeking a Quality Assurance Compliance Specialist to provide support for Quality Assurance compliance.

Your most Innovative career move is here!

At Corium Innovations, we’ve led the way in innovating drug delivery technologies for millions of patients whose GI systems just can’t tolerate pills, who can’t remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There’s so much more to deliver, and we need YOU to do it!

Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients.

Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution.

Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.

• Celebrate Individuals: We ’ re looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.
• Successful Together: We believe we ’ re better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.
• Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners.
• Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

Responsibilities:

• QA Compliance: Uses technical, regulatory, and cGMP knowledge to provide compliance oversight to all Operational areas.
• 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 Quality Assurance liaison to internal customers.
• Maintain the training system.

Qualifications:

• High School Diploma or GED.
• Bachelor’s Degree, preferred
• Minimum of 2 years of related work experience 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.
• 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.