Quality Assurance Operations Specialist - 3rd Shift

Corium Innovations; Grand Rapids (MI); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, vision

Flexible spending accounts

Life insurance

Disability insurance

Employee assistance program

401(k) with company match

12 paid holidays

Vacation and shutdown leave

Job summary

Corium Innovations is seeking a Quality Assurance Operations Specialist for the 3rd shift (10pm–6am, Monday–Friday) to support QA operations on the manufacturing floor. This role requires strong knowledge of cGMP, GDP, and FDA guidance documents, with a focus on accurate record-keeping and timely issue resolution.

The ideal candidate will have a science degree and at least 2 years of related experience in a FDA-regulated environment, plus excellent interpersonal skills to collaborate with

Qualifications

• Requires knowledge of Quality Assurance principles and cGMP regulations.
• Familiarity with FDA guidance documents and regulatory submission requirements is preferred.
• Ability to maintain accurate records and communicate clearly with manufacturing teams.

Responsibilities

• Provide on-the-floor quality oversight of manufacturing operations for commercial and development projects.
• Review executed manufacturing records for GDP and cGMP compliance.
• Review documentation and authorize release of raw materials, WIP, and finished goods.

Skills

Quality Assurance

cGMP

FDA regulations

Record keeping

Attention to detail

Interpersonal skills

Education

Bachelor’s Degree in Science

Job description

Due to our continued growth, Corium Innovations is seeking a Quality Assurance Operations Specialist – 3 rd 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.
• 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 3 rd shift hours, 10pm-6am Monday – Friday.
• 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.