Quality Document Control Specialist

Company Description

At medmix, our team is focused on a single mission, to provide innovative solutions that help millions of people live healthier and more confident lives. Join us to expand your career opportunities in a high growth business, where your unique skills are valued.  

We are looking for a Quality Document Control Specialist to join us at medmix, at our new Greenfield Site outside of Atlanta, Georgia USA. This exciting opportunity will allow you use your skills to identify areas of improvement and propose recommendations to management. You will lead and drive the implementation of your recommendations and assess its impact to the business. If you are eager to learn, strive for personal development, are highly motivated and organized, and a great communicator, you can help us drive medmix to the next level.  

Job Description

Job purpose

Responsible for managing the electronic Document Control System per quality, regulatory requirements and industry best practices.                                                                                                                                                          

Main Accountabilities and Tasks:

1. This position will have responsibility as process owner for Document and Change control within the Quality Management System.
2. Manages the administration of Document Control activities.
3. Owns and provides oversight and guidance of Document, Change and Records Control Processes and Framework.
4. Ensures that documents and change records are routed, reviewed, approved, controlled and implemented in accordance with established procedures.
5. Proactively identifies areas of opportunity within the Document Control and Change Control processes and drives strategic solutions to deliver continuous improvement and optimization.
6. Establishes strong relationships with key customers and stakeholders to foster compliance with Document Control and Change Control initiatives.
7. Acts as a quality representative within the organization, raising awareness for quality.
8. Assists on a variety of projects and participates in daily Quality activities.
9. Suggests and assists with continuous improvement projects within the Quality System.
10. Publication and administration for all new, obsoleted, revisions of controlled documents.
11. Monitors document approval requirements.
12. Collaborates with Training Associate for new and revised document training needs.
13. Provides guidance and direction cross-functionally for company document control needs.
14. Support internal/external audits and activities as it relates to FDA inspections and ISO certification/surveillance audits.
15. Demonstrate problem solving and trouble shooting skills.

Qualifications

Work Experience: 0-2 years of experience manufacturing in a quality environment.

Education: Bachelor’s degree in Industrial Engineering and/or Technology/Engineering or combination of education and experience

Other:

1. 0-2 years of experience using quality management tools.
2. Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software.
3. Knowledge of ISO standards or the ability to quickly learn and retain knowledge as required for system compliance.
4. Ability to perform work accurately and thoroughly and to work independently with minimal supervision.  
5. Must be organized and have the ability to follow a systematic method of performing tasks and the ability to organize and direct a project to completion. 
6. Ensures manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.
7. Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.
8. Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
9. Ability to work well with subordinates, peers and superiors in all departments.

Additional Information

Benefits we offer:

• An innovative, vibrant and agile culture 
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including
  • Unlimited Paid Leave
  • Twelve (12) company paid holidays per year
  • Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
  • medmix Employee Savings Plan / 401k with