QA Document Control Inspector

Job Title QA Document Control Specialist

Organization Name InvaGen Pharmaceuticals

Location 550S Research Place, Central Islip, NY 11722

Work Hours/ Shift

In Office 8:30 AM a" 5:00 PM

Responsibilities

Works with manager to determine what documents must be packed up and what will stay * organize the locations in the room for various documents for all 3 units * Index the contents of the room for easy retrieval in the event of inspection or for review * Box up older documents that need to be sent off site for extended storage at Iron Mountain * Index to be updated on daily basis based on the incoming documents. * Logs to be maintained. * Contact iron mountain to have documents picked up. * In the event of an inspection or department review, review index to determine where the requested document (s) are located. * Contact Iron Mountain to retrieve the document/storage box when needed * When box is received notify the department that made the request that it has arrived. * Log out the document(s) that are being removed and have person removing them sign for them. * Other duties may be assigned as necessary. * Provide support during FDA inspection or audits. * Other tasks may be assigned

Competencies required to fulfill the area of responsibilities and work assignments: *

Education: AS degree (minimum) or equivalent experience in documentation of pharmaceuticals or other Life Sciences. *

Experience: 1-3 years prior Quality Assurance experience of working with documentation systems within a pharmaceutical cGMP environment is preferred. *

Must be able to read and speak English.