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 – 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.