Quality Specialist II

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

• Bachelors 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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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 worlds 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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)

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Required Experience:

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