Sr Quality Assurance Associate
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POST DATE 9/8/2016
END DATE 10/9/2016
Ionis Pharmaceuticals, Inc.
JOB DESCRIPTIONIonis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat complex and challenging diseases. We are the pioneer in the discovery and development of antisense drugs with more than 1300 patents.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in over 27 years and our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
SENIOR QUALITY ASSURANCE ASSOCIATE
This individual s primary responsibility will be to support the compliance and quality of Ionis Drug Substance and Drug Product manufacturing and testing activities with respect to Ionis Quality System procedures and applicable domestic and international regulatory expectations and requirements. Principle duties include, but are not limited to: (1) ensuring progress and completion of responsibilities in accordance with established departmental goals and objectives or project plans; (2) executing and managing the Environmental Monitoring and water testing programs, and (3) using judgment to develop solutions to a variety of moderately complex problems and issues.
Ensure the compliance of Ionis manufacturing and testing activities with respect to Ionis procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements
Coordinate and/or perform collection and processing of samples for environmental monitoring and water testing; manage the receipt and review of test results; prepare monthly, quarterly, and annual trend reports as required per relevant procedures
Perform batch record review and lot disposition activities for raw/starting materials, reagents, intermediates, and drug substance
Review analytical data packages associated with stability testing for drug substance and drug product. Recognize and communicate trends associated with the data over time
Resolve moderately complex investigations and events as directed by area management
Review SOPs, logbooks, and other documentation related to daily QA activities
Perform internal audits of Ionis cGMP operations and perform external audits of Ionis suppliers and contractors, as necessary
Provide support for external regulatory or partner GMP audits
Develop and implement enhancements to Ionis quality system procedures
Other duties as assigned