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Summary


Senior Quality Assurance Specialist
Job Code 201710

 

Job Description

This position reports to the Sr. QA Manager, and is responsible for QA support of Vical’s quality systems, compliance and manufacturing operations. Principal responsibilities are the development and maintenance of commercial quality systems, compliance oversight and quality systems facilitation.

Compliance support may include, but is not limited to the following:

  • Collaborate with internal and external department personnel on commercial readiness preparations, including Pre-Approval Inspection (PAI) readiness
  • Preparation and support for regulatory and partner audits
  • Lead/support continuous improvement projects
  • Internal and external audits
  • GMP and quality systems training
  • Vendor/supplier oversight
  • Data integrity initiatives

Quality systems support may include, but is not limited to, ensuring the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending for the following quality systems (as applicable):

  • Lead in the development of commercial cGMP systems by performing gap assessments of SOPs against regulations and industry standards
  • Creation, revision, review/approval of changes to Vical controlled documents using MasterControl
  • Deviations
  • Corrective/Preventive Action (CAPA) plans
  • Out-of-Specification/Out-of-Trend (OOS/OOT) results
  • Nonconforming material investigations
  • Review of production, packaging, and labeling records
  • Disposition of product, in-process and raw materials
  • Environmental monitoring excursions
  • Review and approval of stability studies

Occasional Manufacturing support may include, but is not limited to:

  • Periodic person-in-plant oversight of manufacturing operations
  • Manufacturing line clearances and floor support for deviations
  • Class 10,000 and 100,000 gowning qualifications
  • Visual inspections of finish product vials

Other duties as assigned

Education and Qualification Requirements

  • A Bachelor's degree in physical science or engineering with a minimum of eight (8) years of Quality Assurance experience in a pharmaceutical / biotech industry is required
  • The position requires prior experience with and extensive knowledge of commercial quality systems, cGMP, regulatory and industry standards.  Additional experience applying phase-appropriate GMP requirements for pre-commercial phases of drug development is preferred
  • Must have strong critical thinking skills, initiative, integrity, strong interpersonal and leadership skills
  • Must have a strong work ethic and a proven track record of managing a high workload and multiple priorities with minimal supervision
  • The ability to communicate clearly and precisely, both orally and in writing, is essential
  • Experience at a commercial, parenteral or API manufacturing facility for biologics is strongly preferred
  • Knowledge of European and Japanese GMP requirements is desired

Vical's Equal Employment Opportunity Policy

Vical is committed to a policy of equal employment opportunity. In keeping with our policy, Vical will recruit, hire, train and promote into all job titles the most qualified individuals, without regard for race, color, religion, sex, sexual orientation, national origin, ancestry, age, marital status, veteran status, disability, medical condition, usage of family and medical leave, or usage of pregnancy disability leave.



Apply for this position    

HOW TO APPLY

To apply, please reference the specific job code in your cover letter and submit with your C.V. or résumé to Human Resources:

By email: hr@vical.com
By fax: 858-646-1154
By mail:
Human Resources
Vical Incorporated
10390 Pacific Center Court
San Diego, CA 92121-4340
U.S.A.
P. 858 646 1100 10390 Pacific Center Court, San Diego, California 92121
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