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QA Document Control Specialist
Trispoke Managed Services Pvt Ltd
- United States
- United States
Über
QA Document Control Specialist Location:
Central Islip, NY 11722 Work Hours/Shift:
Onsite, 8:30 AM - 5:00 PM (Monday - Friday) Position Overview
The QA Document Control Specialist will play a key role in managing, organizing, and maintaining controlled documents within a cGMP pharmaceutical environment. This individual will support document lifecycle activities, archiving, retrieval, and compliance tracking, as well as provide assistance during inspections and audits. Key Responsibilities Collaborate with the manager to determine which documents should be archived, retained onsite, or sent to offsite storage. Organize and maintain document storage areas across multiple units for efficient retrieval. Index, update, and track documents daily to ensure accuracy and compliance. Prepare and package older documents for offsite storage at Iron Mountain. Maintain logs of incoming, archived, and retrieved documents. Coordinate with Iron Mountain for document pick-up, storage, and retrieval. Support internal reviews and regulatory inspections by locating and providing requested documents. Log out and track removed documents, ensuring accountability with proper sign-off. Provide support during FDA inspections, internal audits, or customer audits. Perform other related duties as assigned. Qualifications & Competencies Education:
Associate's degree (minimum) in Life Sciences or related field; equivalent experience will be considered. Experience:
1-3 years of Quality Assurance or Document Control experience in a cGMP pharmaceutical environment preferred. Strong organizational and record-keeping skills with attention to detail. Familiarity with document control systems in FDA-regulated industries. Ability to read, write, and communicate effectively in English. Proficiency in maintaining logs, indexes, and supporting compliance documentation. Demonstrated ability to work independently and as part of a team.
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Sprachkenntnisse
- English
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