Quality Systems Document Control Associate

Industry

Pharmaceuticals

Advert ID

FOX_BBBH41077

Location

Deerfield

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Ohio/W.PA Engineering - (USA) 6000 Lombardo Center Suite 400 OH Seven Hills , OH 44131

ContactNumber

216-901-8600

Job Description

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Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.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