Quality Control Documentation Specialist
- Expired: over a month ago. Applications are no longer accepted.
Review device history records (DHRs) and associated QC test records for completeness and verify accuracy of the records
Provide compliance reviews of Incoming Goods Inspection Forms, Equipment logbooks,Test Records, Quality Irregularity Reports, Solution Prep documentation, and Laboratory notebooks for Quality Control.
Collaborate with QC and Production to resolve DHR discrepancies or errors as related to Good Documentation Practices , SAP inventory, or product release to market
Organizing, filing, and archiving DHRs, QIRs, and other quality records
Preparation, editing and publishing of test procedures, standard operating procedures, and other applicable quality documents.
Support special projects for QC Preanalytics and QC Bioscience as assigned
Other duties as assigned
Edit, update, and maintain relevant procedures for quality department according to quality guidelines.
Review and approval of QC Documentation
Communication and information exchange with affiliated Greiner facilities.
Training of QC employees regarding QC procedures and documentation.
Functions related to SAP QM module Key User
Minimum high school diploma; Bachelor’s Degree in life sciences or related field is preferred
At least 3 years of experience in FDA regulated manufacturing facility, quality position preferred
Demonstrate knowledge of a quality management system
Must have sufficient communication and writing skills.
Must pass pre-employment test.
Must have basic computer knowledge and MS office skills.
Must be able to stand and walk for up to 8/12 hours.
Must be able to lift up to 70 lbs.
Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.
Greiner Bio-One feels like home.
For visionaries with drive and ideas;
For team players who share their knowledge and entertain new ways of thinking;
For people who are able to laugh at themselves and are proud to make a difference through their work.
Our door is always open to achievers, doers and hidden talents and we want to show you what it means to be part of our team.
Greiner Bio-One USWhy Work Here?
AWESOME BENEFITS!!! A company culture where you are valued!
Curiosity is in our genes. Greiner Bio-One employs visionaries who, rather than just waiting, help to shape the future of biotechnology with their drive and forward-thinking. We are team players who share our knowledge and entertain new ideas. We work in a future-oriented environment. What’s more, we value individuality, stability and purpose, since these are the qualities that make us strong. Greiner Bio-One employs people who are able to laugh at themselves and are proud of achieving something worthwhile through their efforts. Future in our Blood. Greiner Bio-One feels like home. For visionaries with drive and ideas; For team players who share their knowledge and entertain new ways of thinking; For people who are able to laugh at themselves and are proud to make a difference through their work. Our door is always open to achievers, doers and hidden talents and we want to show you what it means to be part of our team.
ManufacturingView all jobs at Greiner Bio-One US