Job Description

Job Title:  Quality Systems Documentation Specialist

Pay:  $25.00 - $28.00

The Quality Assurance Specialist functions as a regional role supporting all company sites ensuring QA data and reports subject to FDA inspection are in alignment with SOP and cGMP requirements. The QA Specialist is responsible for the processing of electronic Change Notices using the Documentum Electronic Document Management System (EDMS) and paper-based Document Change Notices (DCNs) and preparing metrics that report on the compliance of cGMP documentation. The QA Specialist also assists department Material Part Number assignment for Finished Products to ensure accurate, consistent, compliant and efficient maintenance of records. The QA Specialist role interfaces with the departments of Innovation & Development, Regulatory Affairs, Contract Manufacturing, Packaging Development and Sales & Marketing to ensure accurate approval of documentation and in support of new Product Launches.

Job Description:

• Verifies compliance of all cGMP documents and data processed including, but not limited to, the document types of electronic Change Notices, paper-based Document Change Notices, Policies, SOPs, Specifications, Methods of Analysis and Protocols.
• Coordinates and issues Document Change Notices (DCNs) associated with GO NAM sites, Packaging & Development, Regulatory Affairs, Contract Manufacturing, Innovation & Development and Sales & Marketing.
• Ensures on-time review and approval processing of cGMP documents.
• Performs training of employees on Documentum software functionality.
• Generates and distributes monthly metrics reporting on the status of Change Notices routing for review and approval.
• Performs weekly follow up of Change Notices to ensure processing towards completion.
• Generates and distributes monthly metrics reporting on the status of 36-month document reviews of Policies and SOPs to facilitate compliant processing.
• Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.
• Administers NAM procedure compliance assessments on the publication of Global Quality Management documents to ensure assessments evaluate global processes against local processes.
• Generates and distributes document indexes of regional policies and SOP's on a timely basis.
• Serves as back-up Documentation Coordinator to the Regional GO NAM.
• Serves as back-up to the Quality Data Specialist for NDC number and Product Code assignments.
• Maintains documentation archives to ensure documents are orderly, complete, accurate and readily available for inspection.

• Bachelor of Science/Bachelor of Arts degree or equivalent work experience required, with a minimum of 3 years of QA experience in the pharmaceutical or related industry.
• Working knowledge of GMPs and related Quality System processes is required.
• Experience with Documentum Electronic Document Management System (EDMS) is required.
• Knowledge of SAP /Quality Management module.
• Quality Management module.
• Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application.
• Good oral communicational and interpersonal skills is required.
• Good organizational skills is required.
• Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory).
• Working knowledge of automated record keeping/retrieval systems is desirable.
• Working knowledge in the software applications of Microsoft Excel and Microsoft Word.
• Background in Quality inspections preferred.