1 Year Contract
Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform.
- Creation and control of Production logbooks pre, post and during use.
- Maintaining document control through Production Floor Support, including but not limited to exchanging inactive official copies of documents for active official copies of documents in real time.
- Supporting production needs by being responsible for performing administrative tasks such as gathering and preparing documentation to support investigations, operational optimization and/or change controls/CAPAs
- Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times for the Antigen Vaccine Platform.
- Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
- Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
- Experience: 0-3 years
- Attention to details
- Able to gown aseptically multiple times throughout the course of a day.
- Working knowledge of cGMP is required
- Good Communication skills both written and verbal
- Proficiency in WORD, and EXCEL, and have a working knowledge of other MICROSOFT OFFICE programs.
- Excellent organizational skills.
- Sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
- Work quickly with a high degree of accuracy.
- Technical Writing experience preferred
Previous experience working within a production department of a pharmaceutical company preferred
- Candidate must be able to work extended and flexible hours (including weekends) when needed.