Role OverviewResponsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. Oversees operations and assures documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
What You Will Do
Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
Why It Might Be a Fit
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.
Requirements
- BS or BA in related field required with 2 years of experience, or MS with no experience required
- Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field
- 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.)
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