POSITION PURPOSE
The Document Control Coordinator will be working with multiple business units to develop, update, and improve quality & regulatory affair processes. Primarily responsible for SoftExpert software implementation, maintenance, and training. You’ll also assist the global medical device strategy implementation.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Learn and become proficient in the Soft Expert System used for archiving, managing, and accessing Quality Documents.
- Point of contact for managing document changes and activities using Soft Expert.
- Identify specific process improvement as needed and provide recommendations concerning established workflows.
- Creation of new forms required for use in UK/EP. Scripting, workflows and helping with validations.
- QMS related training in SoftExpert training module. Administration, set up, creation and scheduling with employees.
- Work directly with Research & Development on the new product development module.
- Work with production and shipping on preparing customer shipping documents.
- Take ownership of responsibilities and drive change both locally and within the Collagen Solutions Network.
- Maintain open communication with management, co-workers, customers, and counterpart staff in other sites.
- Contribute to implementation of new requirements and compliance with the quality management system.
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and benchmarking state-of-the-art practices.
- Take on additional responsibility as directed by management.
QUALIFICATIONS
2 years of relevant experience.
KNOWLEDGE & SKILLS
- Computer literacy and strong skills with Office 365.
- Understanding of ISO 13485, GMP, HACCP.
- Problem solving skills.
- Excellent verbal and written communication skills, strong attention to detail and ability to work as a team.
- Must be highly organized with the ability to manage and prioritize multiple projects/tasks.
- Ability to lift and/or carry > 25 lbs.Proficiency in English.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
