Quality Assurance Operations Specialist - 3rd Shift

Due to our continued growth, Corium Innovations is seeking a Quality Assurance Operations Specialist – 3rd Shift to provide support to Quality Assurance operations. 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

Applies 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.

Qualifications

High School Diploma or GED. Bachelor’s Degree in a science field preferred. Minimum of 2 years of related work experience; FDA regulated industry 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 3rd shift hours, 10pm-6am Monday – Friday.

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.