Quality Control Scientist

Corium Innovations • Grand Rapids, MI

1d

About The Position

Corium Innovations is seeking a Quality Control Scientist to perform laboratory benchwork, analytical data review, and method validation and verification activities, including drafting and execution. The role also performs corrective and preventive actions and conducts and documents laboratory investigations. The position has a broad range of responsibilities in support of the company’s development and manufacture of healthcare products.

Requirements

• Bachelor’s degree in a science-related discipline.
• At least 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.
• Computer skills and knowledge of basic statistical tools.
• Strong oral and written communication skills.
• Proactive approach and attention to detail.
• Chemistry skills, including knowledge of instrumentation.
• Ability to collaborate and interact with all organizational levels and functional areas, internally and with customers.
• Knowledge and understanding of method validations, compendial verification, and method transfers.

Nice To Haves

• Waters Empower 3 Chromatographic Data System experience is recommended.
• Waters Empower 3 Administration experience is preferred.

Responsibilities

• Evaluate drug, medical device, cosmetic products, and raw materials using HPLC, GC, dissolution, UV-Vis, FTIR, and other chemical, physical, and mechanical testing methodologies and technologies.
• Execute general laboratory control procedures, including document control, filing, and controlled sample records.
• Use professional concepts aligned with company objectives to solve complex problems creatively and effectively.
• Perform and assist with investigations to ensure timely and effective review of out-of-specification (OOS) situations.
• Create written procedures, methods, and instructions for laboratory activities.
• Maintain laboratory activities, including glassware washing, waste removal, solution preparation, lab supply purchasing, 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 actions with appropriate assistance.
• Communicate quality information appropriately, accurately, and in a timely manner.
• Create and implement procedures to achieve and maintain compliance with FDA, DEA, ISO, and customer requirements.
• Participate in product development teams and manage projects as appropriate.
• Solve complex analytical problems and recommend and implement continuous laboratory improvements.
• Serve as a subject matter expert for new and ongoing analyst training and development on analytical methodologies and technologies.

Benefits

• Medical, dental, and vision benefits.
• Flexible spending accounts.
• Life insurance and disability insurance.
• Employee assistance program.
• 401(k) retirement savings account with company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan plus approximately one additional week of paid time off for the annual holiday shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level