Quality Control Scientist Corium International
THIS JOB HAS EXPIRED Major Responsibilities
The Quality Scientist is a professional opportunity responsible for the analysis of Rx drug products, OTC drug products, controlled substances, raw materials, and medical devices. Demonstrates organizational, problem-solving, and teambuilding skills.
Evaluate drug, medical device, and cosmetic products and raw materials using HPLC, GC, Dissolution, UV-Vis, FTIR, and other chemical, physical, and mechanical testing methodology.
Execute general laboratory control procedures including but not limited to document control, filing, and controlled sample records.
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.
Maintain, operate, troubleshoot, and calibrate inspection, measuring, and laboratory equipment.
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.
Successful candidates will have a Bachelors degree in chemistry (or equivalent) and a minimum of 4 years of analytical experience in a pharmaceutical industry. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks, while maintaining quality at all times. Demonstrates excellent interpersonal, communication and documentation skills. Works under general supervision and provides leadership and guidance to coworkers. Can independently write technical documents. A wide degree of creativity, latitude, and independent judgment is required.
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.
Excellent communication skills including well developed oral and written communication skills.
Proactive with attention to detail.
||Grand Rapids, MI |
THIS JOB HAS EXPIRED