Document Control Specialist, DEA
Company: Amneal Pharmaceuticals
Posted on: January 16, 2022
* The document control specialist is responsible for administering
the processes and practices which support documentation compliance.
The Specialist will work in a pharmaceutical production facility
and in close collaboration with Quality Assurance, Quality Control
and Production with a key-focus on documentation accuracy, quality
* Manage document control processes thru electronic systems and/ or
paper base systems. Distribute approved documentation to
appropriate personnel, track receipt of documentation and
* Maintaining lists and postings required for both electronic and
hard copy; maintain specific databases in DEA Document Control Room
along with training records.
* Perform data entry and management in systems (DEA NY, NJ &
Kentucky Folders along with (SOMS) Suspicious Order Monitoring
Systems and maintain the print/soft copies for all documents.
* Collaborate with DEA Compliance & Security teams to complete,
maintain an up-to-date Document Control Systems.
* Store, archive, and retrieve the DEA & Security documents such as
SOMS Pended Reports, Questionnaires, Monthly Inventories (API,
Finished Goods, Bulk, Manufacturing, Analytical, Security Systems)
and report files.
* Prepare and distribute SOPs, monthly Finance, Security reports
and other controlled documents.
* Distribute approved documentation to appropriate personnel, track
receipt of documentation and folders. Track document approvals and
any related activities and ensure on-line documents are updated and
* Work with other departments to clarify and correct documentation
to ensure compliance.
* Organize and maintain the work area and keep up-to-date
* Prepare documentation for third party inspection/audits. Assist
Compliance Auditors with documentation and with their various
Controlled Substance Records requirements.
* High School or GED General HS Curriculum - Required
* Associate Degree Any discipline - Preferred
* 2 years or more in Legal, Pharmaceutical or Regulatory Document
* 2 years of Legal, Pharmaceutical or Regulatory Document Handling
* cGMP and computer skills (MS Word, Access and Excel) and highly
organized - Advanced
* Multitasking and flexibility to accommodate changing priorities.
**Title:** *Document Control Specialist, DEA*
**Requisition ID:** *21066*
Keywords: Amneal Pharmaceuticals, Westport , Document Control Specialist, DEA, Accounting, Auditing , Brookhaven, Connecticut
Didn't find what you're looking for? Search again!