*Overview* We are seeking a detail-oriented and organized Document Administrator to join our team. The ideal candidate will play a crucial role in managing, organizing, and maintaining documents in compliance with industry standards.
This position requires proficiency in document management systems and a strong understanding of ISO standards, particularly 21 CFR Part 211 and OTC monographs. The Document Administrator will ensure that all documentation is accurate, accessible, and properly archived.
*Responsibilities*
Manage and maintain electronic and physical documents to ensure compliance with 21 CFR Part 211 standards.
Organize files systematically for easy retrieval and reference. - Utilize SharePoint for document storage, sharing, and collaboration.
Conduct regular audits of documentation to ensure accuracy and completeness.
Proofread documents for grammatical accuracy, clarity, and adherence to company standards.
Implement effective records management practices to maintain the integrity of documents.
Collaborate with various departments to gather necessary documentation and support administrative tasks as needed.
Assist in the development and maintenance of document management policies and procedures.
Responsible for processing, tracking and implementing Process Change Orders (PCOs).
Responsible for processing, tracking and implementing changes to Quality Systems Documentation (Quality Manual, Standard Operating Procedures, Work Instructions, Process Guides, Forms, Formulations, Test Methods, DMRs, etc.).
Responsible for the distribution and communication of the status of all controlled documents.
Performs final review and disposition for all controlled documents after required approvals have been received.
Manages current and archived (internal and external) documents (electronic, hard copy, etc.) per Vesta’s record retention policies and procedures.
Reviews final production documentation (paper and electronic DHRs - routers, shippers, labels, etc.) as part of final product acceptance and release process.
Generates certificate of compliance and analysis as required.
Responsible for Barcode Label management.
Supports Customer Complaints and audits by gathering the required information.
Other duties as assigned.
*Qualifications*
Proficient in using SharePoint for document management purposes.
Previous experience in records management or administrative roles is advantageous.
Excellent proofreading skills to ensure high-quality documentation.
Ability to work independently as well as collaboratively within a team environment.
Strong communication skills, both written and verbal.
Completion of two years of college with an associate’s degree (preferred).
3+ years of experience, or any combination of education and experience that provides equivalent knowledge, skills and abilities.
General understanding of 21 CFR Part 211.
Previous experience in an FDA regulated business function-Quality function is highly desired.
Quality function experience in any industry preferred.
Join us as a Document Control Administrator where your expertise will contribute significantly to our operational excellence!
Job Type: Full-time
Benefits:
401(k)
Health insurance
Health savings account
Paid time off
Schedule:
8 hour shift
Monday to Friday
No nights
No weekends
Experience:
21 CFR Part 211: 3 years (Required)
FDA regulations: 3 years (Required)
Document Compliance: 3 years (Required)
Ability to Relocate:
Milwaukee, WI 53224: Relocate before starting work (Required)
Work Location: In person