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Document Control Specialist, DEA

Company: Amneal Pharmaceuticals
Location: Brookhaven
Posted on: January 16, 2022

Job Description:


* 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 and integrity

*Essential Functions:*

* Manage document control processes thru electronic systems and/ or paper base systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and folders.

* 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 accurate.

* Work with other departments to clarify and correct documentation to ensure compliance.

* Organize and maintain the work area and keep up-to-date files.

*Additional Responsibilities:*

* 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 Handling


* 2 years of Legal, Pharmaceutical or Regulatory Document Handling - Intermediate

* cGMP and computer skills (MS Word, Access and Excel) and highly organized - Advanced

* Multitasking and flexibility to accommodate changing priorities. - Advanced

**Job:** **Manufacturing*

**Organization:** **Operations*

**Title:** *Document Control Specialist, DEA*

**Location:** *NY-Brookhaven*

**Requisition ID:** *21066*

Keywords: Amneal Pharmaceuticals, Westport , Document Control Specialist, DEA, Accounting, Auditing , Brookhaven, Connecticut

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