Position Summary:
Support the functions of the Quality Assurance Document Control department with specific focus on improving organization and access to GMP documents.
Essential Job Functions: Responsibilities include, but are not limited to:
· Assist in retention and organizing all GMP documents
· Scan and index related GMP documentation
· Take an active role in continuous improvement projects to improve efficiencies document access
· Retrieve GMP documents upon request from all departments
· Maintain and improve document logs / filing system
· Support inter-company requests for document retrieval
· Other responsibilities as assigned by Management
Qualifications:
· High School Diploma or similar
· Previous work experience, preferably in an FDA regulated industry
· Some knowledge of cGMPs related to US FDA and manufacturing environments
· Proficiency in Microsoft Word, Excel, Outlook, and Microsoft Windows filing systems.
· Ability to communicate effectively, in person and in writing, in an office setting
Physical Demands:
· Required to reach with arms and use hands and fingers to handle documentation and computer controls.
· Required to stoop, kneel, crouch, stand, bend, sit, talk, and hear.
· Must be able to lift and/or move up boxes up to 50 lbs
Work Environment:
· Required to be present in the office to collaborate with peers and supervisors on an as needed basis
· Potential to move between office sites/areas, including stairs, to complete job functions
Personnel Protective Equipment or Attire Required for Position:
· As needed