Job Description
Assists in performance of all aspects of the quality program designed to ensure continuous production of products consistent with established standards by performing the following duties:
- Assists in performing the testing, analysis, and release of plasmid DNA, generation and/or review of Certificates of Analysis and customer letters, and package and shipment of contract plasmids.
- Assists in Incoming Testing of IND_Ready_™ Starting Material.
- Assists in receiving and logging of all contract plasmid materials.
- Assists in maintaining the proper documentation related to Quality.
- Assists in perform SOP development, editing, review and generation.
- Assists in performing Quality assay development and improvement including new equipment.
- Assists in troubleshooting of all quality issues.
- Assists in compilation and review of IND_Ready_™ manufacturing summaries.
- Assists in maintaining extra material inventory.
- Assists in review of lot numbers for Quality Testing Documentation.
- Assists in entering training into excel files.
- Prepares media buffers.
- Washes glassware.
- Serve as a member of the safety committee as required.
- Assists in contacting collaborators with issues regarding their plasmid(s) or issues related to production.
- Assists in Generating memos when collaborators have been contacted.
- Other duties as required.