QA Document Control Inspector

Cipla USA; New York, North Great River (NY, NY); On-site; USD 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a QA Document Control Specialist to ensure effective management of pharmaceutical documentation. This role involves organizing and indexing documents for inspections, maintaining accurate logs, and coordinating with storage services. The ideal candidate will have an AS degree or equivalent experience, along with 1-3 years of Quality Assurance experience in a cGMP environment. Join a dynamic team where your contributions will support compliance and quality in a fast-paced pharmaceutical setting.

Qualifications

• Minimum AS degree or equivalent experience in pharmaceutical documentation.
• 1-3 years of Quality Assurance experience in a cGMP environment.

Responsibilities

• Organize and index documents for easy retrieval during inspections.
• Maintain logs and coordinate with Iron Mountain for document storage.
• Provide support during FDA inspections or audits.

Skills

Quality Assurance

Document Management

Organizational Skills

Communication

Education

AS degree in Life Sciences

Job description

Job Title: QA Document Control Specialist

Organization Name: InvaGen Pharmaceuticals

Location: 550S Research Place, Central Islip, NY 11722

Work Hours / Shift:

In Office: 8:30 AM - 5:00 PM

Responsibilities:

1. Work with the manager to determine which documents must be packed up and which will stay.
2. Organize the locations in the room for various documents across all three units.
3. Index the contents of the room for easy retrieval during inspections or reviews.
4. Box up older documents for extended storage at Iron Mountain.
5. Update the index daily based on incoming documents.
6. Maintain logs of document movements and storage.
7. Coordinate with Iron Mountain for document pick-up and retrieval.
8. In the event of an inspection or review, consult the index to locate requested documents.
9. Notify departments when documents or boxes arrive.
10. Log out documents when removed, and have personnel sign for them.
11. Provide support during FDA inspections or audits.
12. Perform other duties as assigned.

Competencies and Qualifications:

• Education: AS degree (minimum) or equivalent experience in pharmaceutical documentation or related Life Sciences field.
• Experience: 1-3 years of prior Quality Assurance experience working with documentation systems within a pharmaceutical cGMP environment is preferred.
• Must be able to read and speak English.