GMP Documentation Specialist

Contract Pharmacal Corp.; Town of Smithtown (NY); On-site; USD 42,000 - 60,000; Full time

Job summary

Contract Pharmacal Corp. seeks an organized professional to support Quality Assurance Document Control. The role focuses on filing, scanning, indexing, and reviewing GMP records to ensure accuracy and SOP compliance.

Responsibilities include maintaining document logs, retrieving records for departments, and assisting with intercompany communications. Some college coursework or an associate degree is a plus, with preference for FDA-regulated industry experience.

Qualifications

• High school diploma; some college coursework or an associate degree is a plus.
• Previous work experience, preferably in an FDA-regulated industry.

Responsibilities

• Assist with retention and organization of all GMP documents.
• File, scan, and index related GMP documentation.
• Retrieve GMP documents in response to requests from all departments.
• Maintain and improve document logs and the filing system.
• Support intercompany communication and document retrieval requests.
• Review GMP records for accuracy and SOP compliance.
• Other responsibilities as assigned by senior leadership.

Skills

Strong communication

Strategic thinking

Time management

Multitasking

cGMP knowledge

MS Office

Aurantium ERP

Education

High school diploma

Associate degree (preferred)

Tools

MS Office

Aurantium ERP

Job description

Contract Pharmacal Corp. seeks an organized professional to support Quality Assurance Document Control. The role focuses on filing, scanning, indexing, and reviewing GMP records to ensure accuracy and SOP compliance.

Responsibilities include maintaining document logs, retrieving records for departments, and assisting with intercompany communications. Some college coursework or an associate degree is a plus, with preference for FDA-regulated industry experience.