Job Location : Kennesaw,GA, USA
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 1,400 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:
Perform analytical method development, validation, verification and transfer in a regulated environment. Also perform instrument and laboratory equipment maintenance, calibration, and troubleshooting. Support analytical requirements for regulatory submissions and R&D as necessary.
Responsibilities:
* Organize, conduct and evaluate analytical results and testing independently in compliance with applicable methods, protocols, SOP's and regulatory agency guidelines.
* Identify problems, design and perform optimization, development, and validation of lab test methods.
* Perform routine calibration and maintenance of basic equipment and modern analytical instrumentation.
* Training of junior laboratory staff to carry out newly developed and existing methods
* Write and edit scientific documents for validation and lab studies.
* Prepare and analyze data from experiments and present reports in an accurate and timely manner.
* Peer review data generated by other Analytical Chemistry personnel.
* Assist on projects and tasks as may be assigned by Manager (safety, training, audits, etc.).
* Perform lab functions in compliance with GMP, GLP, ISO and OSHA requirements.
* Will effectively complete other functions that may be assigned.
Qualifications:
* A minimum of Bachelor of Science or better in Chemistry or related field.
* A minimum of 3 years of experience working in a medical device, pharmaceutical, quality control or analytical laboratory.
* Experience with analytical method development and validation REQUIRED.
* Experience working in an FDA environment a plus.