Qa Specialist Jobs

The Quality Assurance Specialist functions as a regional role supporting all Fresenius Kabi sites within North America (NAM) ensuring all QA data and reports subject to FDA inspection are in alignment with SOP and cGMP requirements. In this capacity, 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.

• Performs weekly follow up of Change Notices to ensure processing towards completion.
• Serves as back-up Documentation Coordinator to all GO NAM Production Units.
• Maintains documentation archives to ensure documents are orderly, complete, accurate and readily available for inspection.
• Administers NAM procedure compliance assessments on the publication of Global Quality Management documents to ensure assessments evaluate global processes against local processes.
• Works with the IT Support Team to ensure cGMP/quality data is managed according to Documentum functions.
• 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.
• Generates and distributes monthly metrics reporting on the status of Change Notices routing for review and approval.
• Ensures on-time review and approval processing of cGMP documents.
• Generates and distributes monthly metrics reporting on the status of 36-month document reviews of Policies and SOPs to facilitate compliant processing.
• Coordinates and issues Document Change Notices (DCNs) associated with GO NAM sites, Packaging & Development, Regulatory Affairs, Contract Manufacturing, Innovation & Development and Sales & Marketing.
• Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.
• Performs training of employees on Documentum software functionality. Training includes off-site travel in support of all NAM locations.
• Generates and distributes document indexes of regional Policies and SOPs on a timely basis.
• Serves as back-up to the Quality Data Specialist for NDC number and Product Code assignments.

• Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory).
• Experience with Documentum Electronic Document Management System (EDMS) is required.
• Background in quality inspections is preferred.
• Good organizational skills is required.
• 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.
• Working knowledge of automated record keeping/retrieval systems is desirable.
• Knowledge of SAP / Quality Management module.
• 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.
• Working knowledge in the software applications of Microsoft Excel and Microsoft Word.
• Background in the scientific field is preferred.