Description
Job Description - Sr Quality Scientist- Assist functional area in reviewing design history documents, labeling, design transfer documentation and workflows.
- Participate and relate information from project team meetings as needed.
- Review Quality System documentation, including Installation Qualifications and Operational Qualifications.
- Assist and provide support in audits and inspections.
Education
- Minimum: Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, Engineering or related scientific discipline
- Preferred:Masters degree Chemistry, Biochemistry, Moleculare Biology, Engineering or related scientific discipline
Job Related Experience
Minimum (required)
- At least 3-4 years working experience in product development, manufacturing operations and/or quality management (Quality Assurance).
- Ability to work independely and strong track record of successful participation on technical project teams.
- Excellent communication (both written and verbal) and interpersonal skills
Preferred
- 5-7 years working experience in product development and/or quality management (Quality Assurance) in life science inducstry.
- Working knowledge of Medical Device (IVD) and Quality Assurance including but not limited to 21 CFR Part 820, IVD Directive and Good Manufacturing Practice (GMP).
- Strong track record of successful participation on cross functional technical/ project teams
- Proven track record of successful support in FDA inspections and audits.
If interested please contact me on the information provide below.
Thanks!
To find out more about Real please visit www.realstaffing.com