Company Overview
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.
Position Overview and Responsibilities:
To support the TPL and company through performance of aseptic processing, packaging and labeling of allografts, and general lab functions.
- Document vascular allograft attributes.
- Handle cryopreserved allografts.
- Repackage cryopreserved allografts.
- Perform sterile and non-sterile duties for aseptic transfers.
- Receive, inspect, label and document incoming tissue.
- Circulate at dissection.
- Disinfect, assemble and sterilize laboratory instruments.
- Prepare disinfectants, solutions, and intermediates.
- Clean processing areas and general lab area, including laundering of laboratory scrubs and waste disposal.
- Monitor and record equipment parameters.
- Supply stocking and material system.
- Produce complete and accurate documentation/labeling for above functions.
- Complete appropriate training records prior to performing associated functions.
- Perform all functions within Artivion SOP compliance.
- Other responsibilities as assigned.
Qualifications:
- High School Diploma or equivalent (high school students age 18 or above may be considered).
- Experience in medical device or pharmaceutical industry preferred.
- Prefer knowledge of Good Documentation Practice (GDP), Good Tissue Practice (GTP), Good Manufacturing Practice (GMP) and AATB regulations.
- Organized, detail-oriented, and adaptable.
- Capable of following instructions and working without direct supervision.
- Good oral and written communication skills and problem-solving skills.
- Sense of urgency and ability to meet deadlines.
- Strict adherence to following aseptic technique and standard operating procedures.
- Generate manufacturing batch records to comply with regulatory requirements, good manufacturing/tissue practices and standard operating procedures.
- May perform initial check of completed documents for completeness and accuracy.
- Responsible for labeling and packaging of final biological tissue packaging.
- Ability to set-up, change-over and operate labeling and packaging equipment.