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Corium International Inc.
Quality Assurance Specialist - 3rd Shift
Grand Rapids, MI 49512 United States
Corium International, Inc. is a privately-owned company engaged in the research, development and manufacture of advanced transdermal drug delivery technologies and therapeutic products. We develop and manufacture high-quality products that provide a clear advantage and improve the lives of the people who use them. Corium’s outstanding reputation in development, process development, scale-up and commercial production of complex transdermal products has allowed Corium to become a leading developer and manufacturer in the transdermal pharmaceutical industry, building long-term relationships with top-tier customers.
We are looking for a Quality Assurance Specialist to work in our Grand Rapids, Michigan facility. This is an exciting opportunity to work for a rapidly growing organization that provides a stimulating environment for professional advancement and to work on projects that are at the leading edge of drug delivery technology.
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.
General Responsibilities and Expectations
•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.
Position Specific Responsibilities and Duties
•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, NCR, 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.
Education, training, experience:
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.
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