Document Control Coordinator

Corium Innovations; Grand Rapids (MI); On-site; USD 42,000 - 66,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible Spending Accounts

Life insurance

Disability insurance

Employee assistance program

401(k) retirement plan

12 paid holidays

Paid vacation

Job summary

Corium Innovations is seeking a Document Control Coordinator to provide oversight to manufacturing operations for both commercial and development projects using technical, regulatory, and cGMP knowledge.

You will review and release production records, manage batch records, and ensure proper archival of documents, while supporting quality and regulatory teams.

Qualifications

• 2-5 years of relevant document control or QA experience preferred.
• Basic knowledge of Quality Assurance principles, ISO 9001/13485 and FDA cGMP regulations.
• Highly proficient in MS Office applications (Word, Excel, PowerPoint).

Responsibilities

• Review executed production records.
• Prepare executed production records for release.
• Review documentation related to raw material and finished product testing.
• Assemble and issue batch records to manufacturing.
• Issue and review manufacturing and laboratory logbooks.
• Execute document scanning and electronic archival.
• Production floor manufacturing documentation review.

Skills

Attention to detail

Self-motivated

Independent worker

Regulatory compliance awareness

Quality assurance basics

Education

Bachelors or related degree

Tools

MS Office suite

Access

SharePoint

Job description

Corium Innovations is seeking a Document Control Coordinator to provide oversight to manufacturing operations for both commercial and development projects using technical, regulatory, and cGMP knowledge.

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:

• Review executed production records.
• Prepare executed production records for release.
• Review documentation related to raw material and finished product testing.
• Assemble and issue batch records to manufacturing.
• Issue and review manufacturing and laboratory logbooks.
• Execute document scanning and electronic archival.
• Production floor manufacturing documentation review.
• 3-5 years of relevant work experience preferred.
• Highly skilled in MS Office applications including Word, Excel and PowerPoint; Access and SharePoint experience a plus.
• Motivated self-starter.
• Great attention to detail.
• Able to maintain accurate records.
• Ability to work independently under limited supervision and elevate issues as appropriate.
• Basic knowledge of Quality Assurance principles, ISO 9001/13485 and FDA cGMP regulations.
• 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.