Quality Assurance Workflow Approver
Our client, a global leader in the pharmaceutical industry is seeking a Quality Assurance Workflow Approver to join the Emeryville, CA, location. DUTIES Responsible for Quality Assurance review and approval of Document Change Workflows for new or revised documents, in support of various process improvement projects Major Activities: Working in the Atlas Electronic Document Management System, perform initial Quality review of new or revised documents. Review consists of: confirmation of adherence to Internal Standards confirmation of adherence to applicable Regulations identification of document changes that require pre-approval via the GMP Change Control system verification that document changes, initiated in response to a CAPA, capture the full intent of the CAPA determination of impact to referenced documents review for accuracy, consistency, clarity and ease of use by End User Provide clear, actionable comments and/or direct edits, via Atlas system, to aid Workflow Owner in generation of final, approvable document. Participate in Review Meetings, as necessary, to gain alignment and consensus on more complex document changes. Review of Changes and Reasons to ensure all changes have been appropriately captured in the Workflow and that they are properly justified. Review final document in Atlas and provide electronic signature as QA Approver. Provide assistance in other areas, as needed. Skills CANDIDATES MUST HAVE MINIMUM OF 3 YRS SUPERVISORY/MANAGERIAL EXPERIENCE IN THE AREA OF QUALITY ASSURANCE. DO NOT SUBMIT ANY CANDIDATES WITHOUT THIS EXPERIENCE! · Minimum of 4 years of GMP/ISO/QSR and/or QA related experience, at least 3 years of which are in the area of quality assurance and/or compliance. · Minimum of 3 years supervisory/managerial experience in the area of Quality Assurance. · In depth knowledge of Biologic and Device GMPs, associated guidelines, ISO requirements and related regulations. · Ability to quickly and logically evaluate and solve problems on a daily basis, and guide others to do the same. · Ability to make sound decisions and correctly evaluate decisions of others. · Advanced computer skills. · Experience with Electronic Document Management Systems a must; experience with LiveLink system an additional plus. · Familiarity with antigen manufacturing processes highly desirable. · Excellent supervisory and communication skills. · Ability to multi-task in a highly dynamic environment. · Minimum of 4 years of GMP/ISO/QSR and/or QA related experience, at least 3 years of which are in the area of quality assurance and/or compliance. · Minimum of 3 years supervisory/managerial experience. · In depth knowledge of Biologic and Device GMPs, associated guidelines, ISO requirements and related regulations. · Ability to quickly and logically evaluate EDUCATION BS/BA in Biological Sciences w/ 6 years of appropriate experience, or advanced degree (MS, Ph.D., or MBA) with 4 years of appropriate experience Start Date: 07/02/2012 Hours Per Week: 40.00 Est. End Date: 01/02/2013 Hours Per Day: 8.00
Related projectsSearch for freelance jobs
can’t wait for more clients
and advertising. Thank you."