Job Description

Job Title:  QA Specialist 

Pay:  $25.00 - $30.00

Job Description:  The Quality Assurance Specialist functions as a regional role supporting all sites within North America ensuring all QA data and reports subject to FDA inspection are in alignment with SOP and cGMP requirements.

• 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.
• Assists department Material Part Number assignment for Finished Products to ensure accurate, consistent, compliant and efficient maintenance of records. 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.
• 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. Training includes off-site travel in support of all NAM locations.
• 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.

Requirements:

• Bachelor of Science or equivalent industry experience working in the Quality area.
• Minimum of 3 years of experience working in Quality, preferably in the pharmaceutical industry or other regulated environment.
• 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.
• Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application.
• Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory).
• Background in quality inspections is preferred.
• Working knowledge of automated record keeping/retrieval systems is desirable.
• Working knowledge in the software applications of Microsoft Excel and Microsoft Word.