· 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 have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.
Internal Number: #954
About Greiner Bio-One N.A.
Located in Monroe, North Carolina, we provide product manufacturing, distribution logistics and production application support to our customers in Life Science and Clinical laboratories through our BioScience and PreAnyalitic business units.
The BioScience business operation of Greiner Bio-One offers products for the cultivation and analysis of cell and tissue cultures, micro-plates for high-throughput screening, allowing industry and research the most rapid and efficient drug screening, a complete line of dependable ready-to-use general lab-ware tools used in laboratories everywhere, and innovative bio-chip technologies for genotyping to detect gene defects and identify infectious agents.
The PreAnalytic business unit at Greiner Bio-One offers solutions for the collection of human samples under the VACUETTE brand name. Our products are designed in close cooperation with customers, and manufactured to meet the regulations of FDA QSR and cGMP, Health Canada and ISO 13485. Our products and the service we provide are geared toward the daily routine of laboratory medicine.
Greiner Bio-One, developed and sold the first plastic evacuation blood collection tube on the market to p...rovide Phlebotomy, Nursing, and Laboratory professionals with a new level of safety and product effectiveness that would help to eliminate the use of dangerous glass tubes. This level of service to the safety of the medical professional continues today in the products we bring to customers. Our products have extensive clinical backing along with educational programs and materials to help assure our customers that they will deliver the best possible results for their patients.