Pharma Document Control Specialist (1st Shift)

Amneal Pharmaceuticals LLC

Piscataway Township (NJ)

On-site

USD 28,000 - 34,000

Full time

6 days ago

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Benefits offered by this job

Health benefits

401(k) matching

Bonus program

Job summary

Amneal is seeking a Document Control Specialist for its New Jersey pharmaceutical manufacturing facility. You will administer document control processes, ensure cGMP compliance, and collaborate with QA, QC and Production to maintain accuracy and integrity of documentation.

Responsibilities include electronic and paper document control, data entry, training record maintenance, preparation for audits, and archiving.

Qualifications

High School or GED required.
Associate degree preferred.
Less than one year in manufacturing.

Responsibilities

Manage document control processes thru electronic systems and/or paper base systems.
Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
Maintain lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
Collaborate with teams to complete, maintain an up-to-date Document Control Systems.
Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, specifications, methods, protocols, and report files.
Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. 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.