Quality Specialist II

Element Materials Technology; Bend (OR); On-site; 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

Overview

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.

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.

Skills / 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.

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Company Overview

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.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)