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Summary

vical2clg

Quality Assurance Specialist
Job Code 201704


Job Description

This position reports to the Sr. QA Manager, and is responsible QA support of Vical’s quality systems, compliance and manufacturing operations. Principal responsibilities are review and release of batch records and other material files, quality systems facilitation and compliance oversight.

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):

  • Review of production, packaging, and labeling records

  • Disposition of product, in-process and raw materials

  • Deviations

  • Corrective/Preventive Action (CAPA) plans

  • Out-of-Specification/Out-of-Trend (OOS/OOT) results

  • Nonconforming materials

  • Environmental monitoring excursions

  • Review and approval of stability studies

  • Creation, revision, review/approval of changes to Vical controlled documents

Manufacturing support may include, but is not limited to:

  • Manufacturing line clearances and floor support

  • Class 10,000 gowning qualification

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

  • Internal and external audits

  • Preparation and support for partner audits

  • Visual inspections of finish product vials

  • Gap assessments against SOPs, regulations, and industry standards

  • GMP and quality systems training

  

Education and Qualification Requirements

  • A Bachelor's degree in science or engineering with minimum of five (5) years of Quality Assurance experience in a pharmaceutical / biotech industry

  • The position requires extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization is preferred

  • Must have strong critical thinking skills, initiative, integrity, strong interpersonal and leadership skills are critical

  • The ability to communicate clearly and precisely, both orally and in writing, is essential

  • Experience at a commercial, aseptic 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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