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