Due to our continued growth, Corium Innovations is seeking a Quality Control Scientist to perform laboratory benchwork, analytical data review, method validation/verification drafting and executing activities, corrective/preventative actions & perform and write laboratory investigations. This is a unique opportunity to take on a key role with a broad range of responsibilities. 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: - Evaluate drug, medical device, cosmetic products and raw materials using HPLC, GC, Dissolution, UV-Vis, FTIR, and other chemical, physical, and mechanical testing methodology/technology.
- Execute general laboratory control procedures including but not limited to document control, filing, and controlled sample records.
- Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Perform and assist investigations to ensure effective review of OOS situations in a timely manner.
- Create written procedures, methods, and instructions for laboratory activities.
- Maintain laboratory activities including but not limited to glassware washing, waste removal, solution preparation, lab supply purchase, and stability program activities.
- Perform analytical, physical, and mechanical test method validation and transfer protocols as well as equipment validations and qualifications with appropriate assistance.
- Analyze data, perform process studies, and determine action with appropriate assistance.
- Communicate quality information appropriately, accurately, and in a timely fashion.
- Create and implement procedures to achieve and maintain compliance to FDA, DEA, ISO, and customer requirements.
- Participate in product development teams and manage projects as appropriate.
- Solve complex analytical problems, as well as recommending and implementing continuous laboratory improvements.
- Serve as an SME for new and on-going analyst training and development on various analytical methodology/technology.
- Bachelor's Degree in a science related discipline.
- Minimum of 5 years of analytical experience in the pharmaceutical industry.
- Comprehensive knowledge of FDA cGMP, QSR, ISO, and quality assurance principles.
- Experience in quality reporting, trending, and data analysis.
- Analytical, problem solving, and decision-making skills.
- Proven computer skills and knowledge of basic statistical tools.
- Strong communication skills including well developed oral and written communication skills.
- Proactive with attention to detail.
- Chemistry skills including instrumentation knowledge.
- Waters Empower 3 Chromatographic Data System experience recommended. Waters Empower 3 Administration experience preferred.
- Ability to collaborate and interact with all levels and functional areas (internally and with customers).
- Knowledge and understanding of Method Validations, Compendial Verification, and Method Transfers.
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.
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