22 days old

Quality Assurance Associate

Ionis Pharmaceuticals, Inc.
Carlsbad, CA

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. 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.

QUALITY ASSURANCE ASSOCIATE

SUMMARY:

This individual contributor will support the Quality Assurance and Compliance (QA/C) functions that assure the GLP compliance of Ionis Pharmaceuticals.  Plan, conduct and report results of independent audits to assess compliance with regulations, guidelines and internal operating procedures.  Provide consultation of regulations and guidelines through interaction with cross function study teams. Assist with Good Clinical Practice quality assurance activities as assigned.

ROLES AND RESPONSIBILITY:

  • Assist in compliance of Good Laboratory Practice through monitoring of analytical chemistry, bioanalytical/pharmacokinetic and toxicology activities with respect to GLP regulatory requirements, Ionis’ procedures and quality expectations
  • Perform inspections of critical study phase, audit of raw data, and review of reports for analytical chemistry activities associated with Ionis/partnered non-clinical studies
  • Document and report quality and compliance issues to internal/external stakeholders according to required regulations
  • Assist in the review of drug substance and/or research product data and documentation (e.g. GLP Certification of analysis, retest, etc.)
  • Review corrective action/preventive action plans (e.g. SOP and/or protocol deviations, investigations) as assigned
  • Support regulatory inspections (e.g. planning, preparation, and conduct/execution) as assigned
  • Support QA auditing of contracted toxicokinetic and pharmacokinetic vendors, also internal audit (sample management, equipment, training, etc.) as assigned.
  • Support Good Clinical Practice quality assurance activities
  • Gaining knowledge of GLP/GCP/GVP regulations and quality assurance processes and procedure

REQUIREMENTS OF POSITION:

  • Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, etc.)
  • Minimum two - three (2 -3) years’ experience in the pharmaceutical industry. Cross-functional experience with GLP/GCP Quality Assurance experience a plus
  • Demonstrated communication and interpersonal skills
  • Effective problem-solving skills
  • Effective organization, communication, and team orientation skills
  • Ability to initiate assigned tasks and to work independently
  • Effective communication (verbal and written), interpersonal and teamwork skills
  • Ability to establish and maintain effective working relationship with internal and external stakeholders (e.g. scientist, partners, regulators, and vendors)
  • Ability to successfully manage multiple priorities with aggressive timelines at a high level of productivity in an intense work environment
  • Experience using electronic quality management systems (i.e. Veeva, Documentum, etc.)
  • Experience performing internal and external audits is a plus
  • Ability to travel up to 10 - 20% of the time, both domestically and internationally

Excellent salary and benefits package offered.

Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0161

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Posted: 2018-12-24 Expires: 2019-01-23

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Quality Assurance Associate

Ionis Pharmaceuticals, Inc.
Carlsbad, CA

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