Allentown-Bethlehem-Easton Metro Area, PA
1. Maintaining and coordinating the Record Retention process of GMP documents for the Viral Platform. This responsibility includes onsite and offsite record retention.
2. Updating documents within the Q eDoc system, whether administratively or through a Quality system such as Change Control or CAPA.
3. Creation and control of Production logbooks pre, post and ruing use.
4. Creation and control of cGMP forms.
5. 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.
6. Supporting production needs and continuous improvement including change control, CAPA implementation, and operational optimization.
7. Coordinating document revisions between multiple groups to ensure Right the First Time environment, open communication, and to reduce the probability of rework and/or missed work.
8. Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times for the Viral Vaccine Platform.
9. Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.
1. Attention to details
2. Working knowledge of cGMP
3. Good Communication skills both written and verbal
4. Proficiency in WORD, and EXCEL, and have a working knowledge opf other MICROSOFT OFFICE programs.
5. Excellent organizational skills.
6. 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.
7. Work quickly with a high degree of accuracy.