QA Compliance Specialist

Company OverviewImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. HistoryThe Company was founded in 1984 and in 1986, opened its laboratories at 180 Varick Street in New York City. In its early years, the Company focused on immunology-based diagnostics and infectious disease vaccines. This focus resulted in two FDA approved diagnostics and several vaccine research programs, all of which have been licensed to pharmaceutical companies. During the early nineties, the Company's focus shifted from diagnostics and infectious disease to the development of a pipeline of innovative, biologic compounds in the area of oncology. From this pipeline, three investigational monoclonal antibodies are being evaluated in various stages of clinical development. OperationsImClone Systems operates in two locations - its corporate and scientific headquarters at 180 Varick Street in New York City, which houses the Company's research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. The QA Compliance Specialist is responsible for providing GLP support to the Toxicology Lab and preclinical Toxicology studies; and for providing GMP support to Clinical Pharmacology and the QC Stability Group. The activities for GLP include inspections of the Toxicology laboratory in NY, inspections of the Contract Labs used to execute portions of a preclinical study, audits of all data generated for a study, audits of study files, audits of the draft and final reports. All GLP activities include a follow-up report. This position requires ~ 30% travel. 1. Assist in performing QA inspections/audits of preclinical (nonclinical) studies performed according to Good Laboratory Practices (21CFR Part 58) at both ImClone and CRO.2. Summarize report findings in an inspection report and circulate reports to appropriate study personnel.3. Maintain all QA GLP documentation according to local procedures.4. Review data in reports for accuracy against raw data.5. Maintain accurate schedule of all QA inspection activities.6. Partner with the Toxicology group for scheduling inspections and follow up to inspection findings.7. Review draft reports for compliance to protocol.8. Perform periodic inspection of Clinical Pharmacology lab.9. Review clinical study data, study reports and Clinical Pharmacology SOPs.10. Review and audit stability data as necessary to support the Stability Program and Regulatory submissions11. Provide assistance/support with QA evaluation of NCEs 1. A BA/BS degree in the life sciences or equivalent experience. 2. Minimum of 2-5 years experience in the Biopharmaceutical industry including experience in QA and or quality control laboratory.3. Working knowledge of GLP regulations for monitoring preclinical studies. 4. Must have good organizational and time management skills.5. Excellent written and oral communication skills and must be computer literate. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2267554&boardid=749