Quality Document Control Associate

Job Description

JOB TITLE: Quality Systems Document Control Associate

LOCATION: Northbrook, IL 60062

DURATION: 6+ Months

OBJECTIVES:

Responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Medical and Development QMS. Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.

RESPONSIBILITIES :

· Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards.

· Ensure all Quality Documents meet required standards before processing documents in the Company’s Document Management System - Quality Document (ADMS QD) workflows.

· Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.

· Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Document Management System - Quality Document (ADMS QD).

· Support the development, review and delivery of training materials to provide to new users of the ADMS QD system.

· Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards.

· Support Document Control initiatives that lead to process improvements.

· Respond to email inquiries and user support questions.

· Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.

REQUIRED SKILLS:

· Bachelor of Arts/ Bachelor of Science degree BS/BA.

· 2 - 5 years working experience in the pharmaceutical industry, one of which should be within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline.

· Proficiency in Microsoft Office.

Skills and Competencies:

· Strong interpersonal skills and multi-cultural /intercultural awareness, able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.

· Excellent oral and written communication.

· Abili ty to work independently, multitask and shift workload according to department/team priorities.

· Strong planning and organizational skills and experience managing multiple priorities simultaneously.

· Working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).

· High attention to detail.

Job Requirements

RESPONSIBILITIES:

·         Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards.

·         Ensure all Quality Documents meet required standards before processing documents in the Company’s Document Management System - Quality Document (ADMS QD) workflows.

·         Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.

·         Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Document Management System - Quality Document (ADMS QD).

·         Support the development, review and delivery of training materials to provide to new users of the ADMS QD system.

·         Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards.

·         Support Document Control initiatives that lead to process improvements.

·         Respond to email inquiries and user support questions.

·         Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.

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