QA Document Control Specialist
Trispoke Managed Services Pvt Ltd
Job Title: 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
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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.
- 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.
#QADocumentControl #QualityAssurance #DocumentControl #PharmaceuticalJobs #cGMP #FDACompliance #LifeSciencesJobs #QualitySystems #CentralIslipJobs #NewYorkJobs #PharmaQuality #RegulatoryCompliance #PharmaCareers #QualityAssuranceJobs #DocumentManagement #QAJobs
Vacancy posted 4 days ago
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