This job listing has expired and the position may no longer be open for hire.

Process Improvement Manager at Cook Research Inc. in West Lafayette, Indiana

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Process Improvement Manager

Posting Date 1 month ago (8/4/2022 8:51 PM)

Requisition ID 2022-11170 Job Location(s) West Lafayette IN United States Position Type Full Time Company Cook Research Inc. Category Clinical

Overview

The Process Improvement Manager position at Cook Research Incorporated supports the development and improvement of procedures for Clinical Affairs. This includes the maintenance and development of the global clinical quality procedures in collaboration with Clinical Affairs management, stakeholders, and the Quality team at Cook Research Incorporated. This individual also works closely with clinical study teams globally to ensure compliance with procedures, regulations and standards that impact studies (e.g., FDA CFR, ISO 14155, EU MDR).

Responsibilities

• Develop knowledge on local and global regulatory requirements and standards that impact clinical studies
• Provide oversight of the development and maintenance of Quality procedures in response to stakeholder feedback, CAPA implementation, inspection or audit findings, etc. Serve as change owner throughout the change control process

• Review and enter potential non-conformances, work with stakeholders for CAPA resolution, and support internal process and clinical study audits

• Support document workflow and provide editorial support and version control for implementation guidance documents and other product implementation content
• Act as liaison between the global clinical function and the Quality team at Cook Research Incorporated.

• Support clinical vendor contractor selection and management requirements
• Develop, maintain, and present training to global clinical employees and/or work with subject matter experts as they develop training materials for the global clinical function

• Work with individual process owners across Clinical Affairs to ensure that our global processes interweave as needed to create efficiency and consistency

• Assist clinical study teams with quality and compliance aspects of study management

• Provide support during certification audits and regulatory inspections

Qualifications

• Bachelor's degree is required (Health or Life Sciences preferred)
• Minimum of 2-4 years of experience working with quality systems or clinical research required; prior experience with clinical quality systems preferred

• Minimum of 2 years of technical documentation experience preferably in a regulated medical device/biotechnology/healthcare environment

• Must have excellent English grammar, spelling, punctuation, and sentence structure abilities to write clear and accurate documents

• Willingness and capability to handle multiple projects and responsibilities
• Working knowledge of global regulations and standards related to the conduct of medical device/drug clinical studies preferred
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
• Excellent organizational, critical thinking and problem-solving skills
• Excellent written and verbal communication skills including ability to interact with executive level management and regulatory inspectors
• Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues
• Although travel requirements are limited, a willingness and ability to travel as needed
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.





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