Documentation Coordinator

Description ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX� (cetuximab), as well as 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.

GENERAL SUMMARY
Responsible for the review, routing, distribution, labeling and filing of GMP documentation. Update and maintain document tracking databases and archival systems. Administer Periodic Review and Binder Audit programs for GMP documents. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation. Some physical movement of document files/boxes is required; must be able to lift 30 pounds.

ESSENTIAL DUTIES AND RESPONSIBILITIES
1.Prepare and route documentation packages throughout review and approval cycle.
2.Track document approval activities in electronic tracking system; ensuring on-line e-library is updated and accurate.
3.Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.
4.Initiate and track Periodic Document review, to ensure documents are reviewed and revised to reflect current procedure or made obsolete, as necessary.
5.Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete.
6.Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas; maintain records of issuance.
7.Write and/or update departmental Standard Operating Procedures as needed.
8.Attend cGMP training programs as required.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1.A BA/BS degree or equivalent experience is preferred.
2.1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required.

Requirements Please refer to the Job Description for the qualifications.