Full Job Description
The Institute for In Vitro Sciences (IIVS) is internationally recognized as a leader in the in
vitro testing field for promoting the use and acceptance of alternative methods to animal testing. IIVS is seeking to fill a Laboratory Documentation Specialist position in Gaithersburg, MD. This position is on-site and full time (40 hours per week).
Under supervision, the Laboratory Documentation Specialist performs technical reviews of the IIVS study workbooks, is responsible for generating draft reports, issuing protocols for upcoming studies, and preparing completed studies for archiving.
Specific tasks include the following but are not limited to:
1) Check accuracy of the study related documents such as Sponsor emails, Test Article Receipt, IIVS protocols, and workbooks, related to standard, custom, and novel assays/studies. Ensure GLP compliance of these documents.
2) Check conformity of the study design and specifications mentioned in the IIVS protocols with the study workbooks. Check workbooks for proper execution of the study protocol. Ensure GLP compliance as needed.
3) Utilizing study protocols and workbooks, prepare draft reports to accurately present the procedures and results.
4) Generate protocols for upcoming studies using templated documents.
5) Prepare completed studies for shipment to sponsors and for archiving.
6) Practice proper record keeping procedures and GLP compliant documentation practiced at IIVS.
7) Follow written and verbal guidance, IIVS policies and standard procedures.
8) Use PC-based word processor and spreadsheet software.
Specific capabilities may include the following but are not limited to:
1) An understanding of the IIVS protocols, workbooks, and reports related to standard, custom, and novel assays/studies.
2) Working knowledge of the proper record keeping procedures and GLP compliant documentation practiced at IIVS.
3) Demonstrated competence in basic mathematical skills.
4) The ability to comprehend and follow written and verbal guidance.
5) Demonstrated competence in the use of PC-based word processor and spreadsheet software. 6) Effective written and verbal communication skills.