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Quality Assurance Specialist

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Quality
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185102 Requisition #
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Job Summary
The position is based in Westport supporting the Biologics Development project.  It involves the quality system oversight of the upgrade to the Biologics facility for the launch of a new fill finish process, installation of equipment to support the project, New Product Introduction and associated process validation to support regulatory submission and commercial launch.
 
 
 
Key Duties and Responsibilities:
  • Review and approve SDLC documents
  • Establish Quality System audits and schedules for the PFS supply chain
  • Generation of product launch documentation
  • Participate in NPI and Quality Launch Team meetings
  • Review and approve quality system records associated with the project
Job Qualifications
Education and Experience
  • Bachelor’s degree required in a science or engineering discipline
  • Minimum 5 years experience in a quality discipline in pharma/medical device environment
  • Demonstrated knowledge of quality standards and regulations
  • Experience of working as part of internal and external teams to deliver projects
 
Essential Skills, Experience, and Competencies
  • Demonstrated knowledge of validation processes and guidance
  • Proven to be self directed and self-motivated
  • Excellent communication skills managing external partner companies
  • Problem solving ability using risk based decisions

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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