Job Details

Requisition Number 16-0036
Post Date 1/2/2017
Company Ionis
Title Sr Quality Assurance Associate
Employment Type Full Time
Description

Ionis 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.

RESPONSIBILITIES:

  • 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

REQUIREMENTS:

  • Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, engineering, etc.) with at least 3 years of QA experience in the pharmaceutical industry
  • Experience performing batch record review activities and performing systems related internal and external audits, is essential
  • Possess and maintain proficiency in FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations
  • Effective communication (verbal and written), interpersonal, and teamwork skills
  • Must be able to manage multiple priorities with aggressive timelines at a high level of productivity
  • An ability to be productive and successful in an intense work environment

Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #16-0036

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. is proud to be an EEO employer.

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