Document Control Coordinator

Zimmer Biomet; Norfolk (VA); On-site; USD 42,000 - 52,000; Full time

Job summary

Qualifications

• 1–2 years of relevant Records/QA experience.
• Knowledge of FDA regulations (21 CFR 820) and QSRs.
• Experience with document control and record management systems (e.g., Livelink, Windchill).
• Ability to work under pressure and meet deadlines.

Responsibilities

• Review production batch records for accuracy, completeness and compliance with cGMP.
• Create Certificate of Conformances for product release and manage document changes.
• Assist with document control, records management, and ensuring timely publication of changes.
• Support internal and external audits and maintain QMS metrics.

Skills

Batch records review

Document control

QMS compliance

Audit support

MS Office

Education

High school diploma

Tools

Windchill

JDE

Livelink

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Primarily responsible for ensuring that Zimmer Biomet records and systems are well maintained and updated in accordance with Zimmer Biomet procedures and industry standards and regulations.

How You'll Create Impact

Responsible for review of batch records, creating Certificate of Conformances for product release, assisting with document control and records management processes, and for ensuring records are processed, retained, and updated appropriately. Also responsible for assisting with ensuring change orders and documents are processed within a timely manner.

Responsible for review of production batch records and giving direction to team members regarding updates to batch records upon review.

What Makes You Stand Out

• Review of production batch records for accuracy, completeness and cGMP
• Documentation Control / Record Management
  • Configures and implements document change orders
  • Ensures appropriate justification is referenced per change
  • Review and accept/reject the impact assessment to the design change
  • Review and accept/reject the regulatory actions per the change
  • Identify and route document proposed changes to the approval group and manage the document routings through to publication
• Training
  • Schedule training per the document change order requirements
  • Assist with conducting QMS database functionality and responsibilities training
• Compliance
  • Assist Quality Management with ensuring conformance in accordance with the fundamental cGMP & GLP practices.
  • Maintain compliance to internal SOP’s, and any applicable ISO standards that Embody claims compliance to
  • Assist with the compilation and analysis of QMS metrics in support of quality objectives for Management Review
• Audit Support
  • Support Quality Management during internal audits
  • Support Quality management during external third-party audits

This is not a complete list of Duties and Responsibilities and may not necessarily encompass all essential functions of the role.

Competences

Ability to work under pressure while performing multiple tasks and maintain an orderly processing state within a stringent time frame.

Operate scanners and reader/printer.

Possess the ability to learn the basic software applications used within the department.

Ability to create written work instructions and ensure department compliance to them and other established procedures.

Proficiency with, Microsoft Office, Windchill, JDE and Livelink.

Knowledge of advanced filing methods and procedures.

Excellent interpersonal skills, written and oral communication, organizational skills, and attention to detail.

Logical stepwise approach to problem solving.

Your Background

High school diploma in relevant discipline and a minimum of 1-2 years relevant experience.

Experience and knowledge of a variety of computer systems, ideally records management databases.

Knowledge of applicable government regulations including USDA, FDA, etc.

Experience working within most aspects of the Quality System Regulations (QSR’s), such as 21 CFR 820 & ISO 13485 for medical devices.

Experience working for product for medical devices.

Salary Ranges: 41,600.00 - 52,000.00

Travel Expectations

N/A no travel expectations.

This is a 100% Onsite opportunity at Norfolk, Virginia.

EOE/M/F/Vet/Disability