Document Administration Associate I

Lannett Company, Inc.•Seymour, IN

About The Position

The Document Administration (Doc Admin) Associate is responsible for the management of the QA Documents – including but not limited to mastering of QA Approved Batch Records, assessing SAP process orders to determine the appropriate document to issue for production execution, verifying all Quality requirements have been met for document issuance, and managing document retention for all master documentation as well as executed batch records. The Associate ensures all documentation mastered, issued and retained adhere to all LCI SOPs and cGMP guidelines.

Responsibilities

Prepare approved production records for mastering. Prepare approved documents for issuance
Prepare approved specifications and methods for mastering. Work with document control to align effective dates and assure copies created on time and in accordance to governing procedures
Ensure document lifecycles adhere to record retention policies
Attend weekly scheduling meetings to determine the priority for production document issuance
Monitor and maintain SAP process orders for orders that require a production document issued
Verify all Quality requirements (holds. training, stability, etc…) are met prior to issuance
Work with Validation to determine and ensure validation batches are issued in accordance with governing procedures
Train appropriate back-ups on the issuance and checking of issued records
Manage the following types of documents in accordance to document retention procedures. This includes on-site and off-site storage
Effective Master Documents
Obsolete Documents
Executed production and laboratory documents
Log Books
Raw Materials, Packaging Materials, and Labeling Materials
Incoming Finished Goods (CMO records)
Conduct the yearly purge of documents based on governing procedure
Complete Requests for Information in a timely and efficient manner
Validation/Technical Services
Regulatory Affairs
Laboratory
Customer Service