Quality Systems Specialist II — cGMP & Audit Readiness

Element Materials Technology; Bend (OR); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Element Materials Technology is seeking a Quality Specialist II for our Bend, OR laboratory. The role operates in a cGMP environment under the Quality Manager and focuses on quality system procedures and improvement initiatives.

You will collaborate with Quality and Operations to address compliance gaps and support FDA readiness. The ideal candidate will have a engineering/chemistry/life sciences background and 2–5 years of quality experience in a regulated setting, contributing to a culture of

Qualifications

• Bachelor's degree or Diploma in engineering, analytical chemistry or life sciences (microbiology, etc.).
• 2-5 years of 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.
• Close high risk compliance gaps to meet FDA inspection readiness.
• Design and execute Corrective Action project plans relating to customer audit findings and regulatory inspections.
• Quality oversight of the equipment management process (PMs, Calibrations, Qualifications).
• Qualify vendors through the Vendor Qualification Program.
• Evaluate processes to reduce the costs of poor quality.
• Monitor timely completion of routine Quality System tasks and provide updates.

Skills

Quality reviews

cGMP experience

Team collaboration

Education

Bachelor's degree or Diploma in engineering, analytical chemistry or life sciences

Job description

Element Materials Technology is seeking a Quality Specialist II for our Bend, OR laboratory. The role operates in a cGMP environment under the Quality Manager and focuses on quality system procedures and improvement initiatives.

You will collaborate with Quality and Operations to address compliance gaps and support FDA readiness. The ideal candidate will have a engineering/chemistry/life sciences background and 2–5 years of quality experience in a regulated setting, contributing to a culture of