Document Control Specialist

Rebel Converting, LLC.; Milwaukee (WI); On-site; USD 50,000 - 75,000; Full time

Job summary

A leading company in the manufacturing sector is seeking a Document Control Specialist in Milwaukee. The role involves managing document control processes to ensure compliance with regulatory standards. Candidates should possess strong communication skills, experience in records management, and a good understanding of quality systems. This position is ideal for individuals looking to leverage their expertise in a collaborative work environment, contributing to both document integrity and compliance standards.

Qualifications

• 3+ years of experience in records management or administrative roles.
• Completion of two years of college with an associate’s degree preferred.
• General understanding of 21 CFR Part 211, Part 820 or ISO 9001.

Responsibilities

• Manage and maintain electronic and physical documents for compliance.
• Conduct regular audits of documentation to ensure accuracy.
• Collaborate with various departments to gather necessary documentation.

Skills

SharePoint

Proofreading

Communication

Collaboration

Education

Associate's Degree

Job description

SUMMARY: Document Control Specialists are responsible for document management and ensuring records are properly stored and easily accessible. As they need to collaborate with various internal departments, candidates must demonstrate good communication skills.

DUTIES AND RESPONSIBILITIES:

• Manage and maintain electronic and physical documents to ensure compliance with 21 CFR Part 211 standards.
• Experience working with and implementing Good Documentation Practices.
• 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.
• Have experience authoring documents and SOPs as needed.
• 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 Document Change Orders (DCOs).
• 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 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.
• Experience in training and facilitating a training program for all site employees.
• 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, Part 820 or ISO 9001.
• Previous experience in an FDA regulated business function-Quality function is highly desired.
• Experienced in writing procedures and documents in a regulated environment.
• Quality function experience in any industry preferred.