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Quality Control Documentation Specialist

Greiner Bio-One US
Charlotte, NC
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Responsibility:

  • 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

Authority:

  • 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

Job Requirements:

  • 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.

Physical Requirements:

  • 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.

Company Description
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.

Greiner Bio-One US

Why 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.

Address

Charlotte, NC
USA

Industry

Manufacturing

View all jobs at Greiner Bio-One US