Quality Assurance Specialist - Off Shift Corium International
THIS JOB HAS EXPIRED Major Responsibilities
The Quality Assurance Specialist performs duties in support of the Corium Quality Assurance and Regulatory Compliance programs. The QA Specialist is responsible for coordinating, organizing, and completing activities for the development, implementation, and maintenance of projects related to Quality Assurance.
Demonstrated experience and knowledge of FDA cGMP, QSR, ISO, and/or quality assurance principles preferably in the drug or medical device industry.
Communicates appropriately, accurately, and in a timely fashion, significant issues or developments identified during activities and provides recommended process improvements to management.
Excellent communication skills including well developed oral and written communication skills.
Develops new approaches to solve problems identified during activities using sound decision making skills.
Proactive with attention to detail.
Accurate documentation and data collection according to approved Quality System procedures.
Possesses the ability to analyze data and identify improvement ideas with appropriate assistance.
Experience in quality reporting, trending, and data analysis.
PC experience including MS Office (Word and Excel).
Translate QMS objectives into procedures and plans for use in the Quality System.
Serve as QA liaison to internal and external customers for development and commercial products.
Develop and approve procedures, work instructions, and specifications for development and commercial products.
Review quality, engineering, and production control records to determine compliance to approved Quality System procedures, GMP regulations, and customer's requirements.
Facilitate, lead, review, and/or approve DEV and CAPA investigations related to development and commercial programs to ensure effective and efficient completion.
Approve and release product to distribution after determining all required activities are complete and associated documentation is reviewed.
Create Drug & Device Master Records and Drug & Device History Records according to approved procedures.
Four years college level science courses or quality related professional courses/certification preferred, a minimum of 3 years experience in a quality assurance, regulatory compliance, or lab setting in the pharmaceutical or medical device industry required. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety tasks. Works under general supervision. A certain degree of creativity, latitude, and independent judgment is required. Typically is responsible for one or two concurrent projects or duties.
||Grand Rapids, MI |
THIS JOB HAS EXPIRED