Quality Systems Document Control Associate job vacancy

Vacancy expired!

Quality Systems Document Control Associate 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.

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 Document Management System - Quality Document (ADMS QD) workflows. Responsible for ensuring impacted stakeholders are identified and involved in reviews of new and revised Quality Documents. Responsible for effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Astellas Document Management System - Quality Document (ADMS QD). Support the development and review 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. Responsible for responding to email inquiries and user support questions. Participate in the oversight of Quality Document Periodic Review cycles. Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository. QUANTITATIVE DIMENSIONS: Functions as the CRQA point of contact for all functional areas utilizing the M&D Quality Management System. Supports the CRQA staff by offering consultation, advice, and subject matter expertise regarding QMS document control requirements. Processes and manages approximately 125 quality documents per month. ORGANIZATIONAL CONTEXT: Reports to the Director, Quality Systems Document Control. No people management responsibilities Collaborates directly with CRQA Leadership Team, CRQA staff, and various levels within Medical and Development (M&D) functions including other functions outside of M&D that utilize ADMS QD. REQUIRED SKILLS: Bachelor of Arts/ Bachelor of Science degree BS/BA. 1-3 years working experience in the pharmaceutical industry, 1 of which should be within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline. Proficiency in Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).

Vacancy expired!

ID	#15442975
State	Illinois
City	Deerfield
Job type	Contract
Salary	USD TBD TBD
Source	Manpower Engineering
Showed	2021-06-14
Date	2021-06-14
Deadline	2021-08-13
Category	Et cetera
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Quality Systems Document Control Associate

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