Sr. Quality Assurance Specialist: Date Created : 6/19/2014 11:51:48 AM Category : Clinical Location/City : NJ - Lakewood Job Type : Contract Id : 3021174 We are looking for a Sr. Quality Assurance Associate for a leading pharmaceutical development and manufacturing located in Ocean County, NJ. Qualified candidate MUST have 4-6 years QA experience with SOP and protocol writing, batch record review, investigations into deviations and out of specification results and skills in Trackwise. To apply: Please respond directly to Global Employment Solutions, Inc. at rchu@gesnetwork with your resume attached - WORD documentSummary: This position is directly responsible for ensuring that the Quality Investigations group functions in a timely, efficient and effective manner; and performs in compliance with current regulatory and company expectations.Functions: Batch record review of products manufactured by contract facilities. The review may include associated deviations, as well as implementing and tracking corrective/preventive actions, change controls and technical documents (stability protocols/reports, method and process development) Review and approval of distribution instructions, packaging/labeling specifications and executed packaging/labeling records. Review/approval of labels for domestic and international drug supply Review/approve validation documents (internal and external) for equipment, method and processes Develop, administer and maintain quality based procedures and practices with respect to the lab and manufacturing quality assurance investigations and the Corrective Actions (CAPAs) that reflect regulatory expectations and support the business model and company objectives. Review deviations, as well as implementing and tracking corrective/preventive actions MAJOR:Required: Bachelor of Science is preferred Minimum 5 years experience in FDA or equivalent regulated industry biotechnology or pharmaceutical industry and at least 4 years performing Quality Assurance functions (for example; SOP and protocol writing, batch record review, investigations into deviations and out of specification results, training and auditing) Strong working knowledge of cGMP Preferred knowledge and experience in GLP, GCP and ICH guidelines Preferred experience in production and characterization, process development, or assay validation Prior experience and use of Trackwise required MAJOR: Keywords: QA, Sr. QA, GMP, Pharmaceutical Development, Pharmaceutical manufacturing, Sterile manufacturing, Trackwise, CAPA, Sr. QA Consultant, Quality Systems, Design Control Processes, Change Control, SOP and Batch Record development GMP, GLP, GCP Pharmaceutical Development QA, Quality Assurance,implementation, Deviation, CAPA, Quality procedures, Design Control system, Quality Assurance, Sr. Quality Assurance Specialist, Trackwise, Biotechnology MAJOR:To apply - please call Rose Chu at #610-822-1256 to discuss details or send your updated resume to rchu@gesnetwork directly for interview.Rose ChuVice President, Pharmaceutical and BiotechOne Presidential Blvd. North, Suite 310Bala Cynwyd, PA 19004610.822.1256 phone610.822.1210 facsimilerchu@gesnetworklinkedin/in/rosechu dlvr.it/636rxw
Posted on: Thu, 19 Jun 2014 19:17:13 +0000
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