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Title: Research Assistant I
Location: Swiftwater, PA
Job No.: 4557043
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures.Provides assistance in the execution of experiments and analytical procedures by performing routine scientific procedures and experiments according to detailed protocols. Integrates, compiles, and tabulates data and reports results to supervisor. Work is closely supervised. Assignments are task-oriented with detailed instructions. Follows standard practices to obtain data. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience 0-3 years
Skills:This position will be working on special projects within the Sterility Assurance department. Candidate should have experience in project management, technical writing skills (reports, protocols, documents), some experience in or at least an understanding of validation concepts with some experience in a pharmaceutical environment.
Additional skills should include, strong written and verbal communication skills. Systems to be use include, but are not limited to: Trackwise, e-doc (author, reviewer, approver), MASTER, Pharmnet, SAP, LIMS, ISOtrain.
Examples of project(s) are as follows:
- Validation Study to support the use of viable tubing at various lengths. The intent of this validation study would be to show that the length of tubing does not have an adverse impact on recovery rates for viable organisms. This task would involve assessing all site production areas to determine the length of tubing used, developing a study to validate both the shortest and longest length, documented and then driving a protocol through the review and approval cycle, conducting the study in an appropriate location on site, writing report containing the results and then driving through report review and approval cycles. A change control may also be needed to ensure the report is referenced in appropriate documentation.
- Implementation of an alternate EM media to replace DE Neutralizing agar. The project will require development and execution of comparability study/protocol to validate the identified alternative media. The protocol will need to be executed and written by potential candidate. This project will require coordination between other groups on site, such as: Supplier Quality, Quality Control, Quality Assurance, Quality Validation, Sterility Assurance and Operations.
- Create a Matrix approach for Aseptic Process Simulations. This project would involve review and compilation of all pertinent validation documents surrounding Filling and Formulation lines. All critical parameters associated with processes would be identified and risk assessed. This project will involve driving a change control and report through approval cycles.
Education:Candidate should possess bachelor s degree in related field or comparable experience.
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