Quality Specialist II

Element Materials Technology•Bend, OR

10d•Onsite

About The Position

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.

Requirements

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.

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.