QA Compliance Specialist
ImClone Systems Incorporated

General Summary: 

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.

Essential Duties and Responsibilities

Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

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. Periodic inspection of Clinical Pharmacology lab.

9. Review of clinical study data, study reports and SOPs.

10. Review and audit of stability data as necessary.

11. Provide assistance/support with QA evaluation of NCEs
     

Essential Knowledge, Skills, and Experience

1. A BA/BS degree in the life sciences or equivalent experience.

2. Minimum of 1-3 years experience in the Biopharmaceutical industry including experience in QA and/or a research or quality control laboratory.

3. Knowledge of or an understanding 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.