Quality Control Documentation Specialist

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.