Document Control Specialist

Job Description:

Document Control Specialist

This role focuses on managing and controlling quality-related documentation within a medical device manufacturing environment that operates under cGMP/GDP and ISO 13485:2016 standards. The Document Control Specialist issues and tracks critical documents, maintains electronic and physical records, supports quality management system (QMS) activities, and contributes to internal and supplier audits. This position offers the opportunity to work with Agile PLM and Smart Solve systems while supporting a growing organization with strong prospects for career advancement.

Responsibilities

+ Issue document numbers, part numbers, and project numbers in accordance with established procedures.

+ Process all document and drawing changes, including preparation, formatting, distribution, routing, maintenance, and release to authorized users.

+ Manage the manual and electronic routing, tracking, distribution, and retrieval of controlled documents.

+ Create and maintain bills of material using Agile PLM software.

+ Perform document control activities, including assembling batch records, assigning tracking numbers, filing records, and issuing lab notebooks.

+ Maintain document filing systems and electronic databases for archived regulatory and quality information, ensuring timely retrieval upon request.

+ Issue, archive, and retrieve controlled documents such as lab notebooks, audit reports, SOPs, training records, design history records, procedures, work instructions, and released product information.

+ Support ongoing quality assurance programs by performing document-related QA tasks as assigned.

+ Assist with employee training and support the development of QA training materials.

+ Assist with internal audits and participate in vendor and supplier audits, providing documentation and support as needed.

+ Assist in the development of documentation, including batch records and documentation supporting regulatory submissions.

+ Write and/or implement changes to controlled documents such as SOPs, specifications, and methods when needed.

+ Independently interpret, follow, and implement instructions and procedures, and help others understand and implement them correctly.

+ Prioritize multiple projects appropriately and adapt to changing company objectives and timelines.

+ Ensure that document control practices align with QMS requirements and support continuous improvement initiatives.

Essential Skills

+ Experience working in the medical device industry.

+ Knowledge of cGMP and GDP requirements in a regulated environment.

+ Familiarity with ISO 13485:2016 or similar medical device quality standards.

+ Strong experience with Agile PLM software, including creating and maintaining bills of material.

+ Hands-on experience with document management and document control activities.

+ Experience working within a Quality Management System (QMS) and QMS documentation practices.

+ Ability to manage change control processes for documents and drawings.

+ Experience supporting or participating in internal audits and vendor or supplier audits.

+ Proficiency in organizing, archiving, and retrieving documentation in both electronic and physical formats.

+ Ability to independently understand, follow, and implement written instructions and procedures.

+ Strong attention to detail and accuracy in handling quality and regulatory documentation.

+ Ability to prioritize tasks and manage multiple projects in a dynamic environment.

Additional

Skills & Qualifications

+ Experience using Smart Solve or similar electronic quality management systems.

+ Experience assembling batch records and assigning tracking numbers.

+ Exposure to documentation supporting regulatory submissions in the medical device field.

+ Experience creating or revising controlled documents such as SOPs, specifications, and methods.

+ Experience assisting with employee training and developing QA training materials.

+ Strong communication skills to support cross-functional teams and help others follow documented procedures.

+ Comfort working with databases and electronic document management systems.

Job Type & Location

This is a Contract position based out of Northfield, IL.

Pay and Benefits

The pay range for this position is $30.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision  - Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available  - Life Insurance (Voluntary Life & AD&D for the employee and dependents)  - Short and long-term disability  - Health Spending Account (HSA)  - Transportation benefits  - Employee Assistance Program  - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in…