Quality Assurance Specialist Senior 1
Confirmed live in the last 24 hours
CAI

1,001-5,000 employees

Integrated services
Company Overview
CAI brings top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to achieving full-scale production operations, into rigorous asset management, reliability, and sustainability activities.
Consulting

Company Stage

Pre-seed

Total Funding

$3.4M

Founded

1996

Headquarters

Indianapolis, Indiana

Growth & Insights
Headcount

6 month growth

2%

1 year growth

17%

2 year growth

33%
Locations
Seattle, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
QA & Testing
Operations & Logistics
Requirements
  • BS or MS in a relevant science or engineering field, or equivalent
  • 4-8 years' experience within GMP regulated facilities
  • Experience with Aseptic manufacture desirable
  • Excellent oral and written English
  • Able to travel domestically and internationally if required
  • Able to work (paid) overtime
  • Able to work in the US without sponsorship now or any time or in the future
Responsibilities
  • Provide knowledge and experience in Quality Systems and/or Operational Quality
  • Perform Batch Disposition preparation, Batch record review, Certification process oversight
  • Support all quality and compliance requirements for and leading to commercial manufacturing
  • Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement
  • Understand and apply regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes
  • Interpret client’s needs, assesses requirements, and identifies solutions to non-standard requests
  • Ensure the highest Quality, Compliance and Safety standards
  • Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
Desired Qualifications
  • Professional Quality Assurance Accreditation desirable
  • Experience of batch record review and product release essential