Location: Irvine, CA, On Site
Duration : 1 year with potential for extension. Direct Conversion TBD.
Pay: $31/hr
Responsibilities
- Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
- Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
- Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
- Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
- Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
- Capable of using Microsoft programs and ability to learn other systems.
- Working knowledge of statistical methods as well as statistical application software.
- Effective verbal and written communication skills.
- The ability to work in teams and independently with minimal supervision to obtain results as required.
- Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
Requirements
- BS or BA in related field required with 2 years of experience, or MS with no experience required (project management experience preferred).
- Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
