Quality Specialist II

About the role

Element has an opening for a Quality Specialist II position at our Bend, OR laboratory. This position will work in a cGMP-regulated environment under the direction of the Quality Manager. The position will work with a team completing Quality System functions following controlled documents, protocols, and procedures. This position requires working in a collaborative manner with other team members to accomplish organizational goals, provide ideas to improve efficiency, and actively contribute to positive co‑worker/customer relationships. Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’. When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access. While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development. Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Responsibilities

• Perform Quality reviews of issue handling processes (IN/NCR/CAPA).
• Perform Quality Reviews of project protocols and final reports.
• Write and review SOPs and other procedures related to the Quality System
• Work with Quality and Operations to close high risk compliance gaps to meet the goal of FDA inspection readiness.
• Work with the team to design and execute Corrective Action project plans relating to customer audit findings and regulatory inspections.
• Perform quality oversight of the equipment management process (initiating new equipment, PMs, Calibrations, Qualifications, logbook reviews, etc.).
• Work with the Quality team to qualify vendors through the Vendor Qualification Program
• Evaluate processes for inefficiencies and opportunities to “engineer the human error out” and reduce the costs of poor quality.
• Monitor the timely completion of routine Quality System requirement tasks – support staff in completion, follow up on statuses, and provide updates to other QA and management staff.
• Support completion of other quality system tasks, as applicable.

Qualifications

• Bachelor's degree or Diploma in engineering, analytical chemistry or life sciences (microbiology, etc.).
• 2-5 Years experience working in Quality in a cGMP environment.