Allentown-Bethlehem-Easton Area, PA
Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform. This responsibility includes onsite and offsite record retention.
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.
Bachelor s Degree preferred but not required.