The Document Control Coordinator will ensure that the documents are properly controlled in compliance with company procedures and regulatory requirements. The Coordinator is responsible for ensuring released documents are accurate and complete. The Coordinator is responsible for the change control process, document distribution, archiving and retrieving. As a part of Document Control, the Coordinator is also responsible for training documentation.
Essential Duties & Responsibilities
Follow and work in accordance with company policies and procedures to ensure Quality System and regulatory requirements are met in an ethical manner.
- Meet commitments on time with accuracy and attention to detail.
- Maintain, update and archive company documents and records in accordance with company procedures; coordinate the preparation, approval and implementation of these documents as well as archiving and retrieving as needed.
- Maintain security, order and cleanliness of document control area and documentation files.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance, to all departments, regarding these documents.
- Write and/or edit procedures, work instructions, or policies to ensure compliance with current Quality System and regulatory requirements.
- Ensure accuracy of redlines and documentation associated with document change process.
- Assist with training and support organization in the proper use of Word, Excel, and other document related software to ensure proper document formatting and consistency in documentation within the company.
- Monitor external standards that are used within the organization and ensure new revisions are reviewed and maintained within the organization.
- Manage document archival and retrieval services. This includes services to confidentially shred company documents and provide off site storage.
- System administrator for training database maintaining training documentation to ensure evidence of meeting training requirements is readily available.
- Participate in internal, external, or supplier quality audits, providing timely retrieval of all requested controlled documents.
- Assist with the maintenance of the Quality Metrics. Provide support as needed for metrics in Management Review.
- Other Document control duties as assigned
Non-Essential Duties & Responsibilities
- Acts as a consultant for areas related to his/her expertise.
- Participate and assist as a part of the Internal Audit team as required.
- Other duties as assigned, verbal and written.
- Zero to five years of experience working in a regulated industry, such as medical devices or aerospace.
- High School Diploma
- Proficient with Microsoft office software, especially Excel and Word.
- Some knowledge of FDA Quality System Regulation (QSR), ISO 13485:2106, and associated standards preferred.
- Some experience with inspection equipment and methods preferred.
Skills & Abilities
- A technical degree or equivalent in experience is required, with preference to those with some administrative or project management background.
- Team player with flexible attitude and ability to prioritize workload and handle multiple tasks/deadlines within a fast-paced environment.
- Ability to adhere to all processes and procedures.
- Highly organized, attention to detail, self-directed, self-motivated.
- Some technical writing experience.
- Experience formatting documents in MS Word, managing information and data in Excel spreadsheets, and summarizing and presenting information and data in MS Power Point.
- Ability to write and comprehend instructions, short correspondence, and memos in English. (Spanish is a plus.)
- Ability to communicate effectively with all members of the company from most senior management to production line employees.
- Ability to solve practical problems.
- Ability to work in a fast-paced environment and meet deadlines.
- Some knowledge of production and inspection processes is desired, including knowledge of good manufacturing and good documentation practices.
- Motivating, proactive and having ability to promote / create a positive and productive work environment.
- Have conciliatory skills in human conflicts.
- Experience with writing procedures or policies.
- Familiar with a Quality Management System (such as ISO 13485:2016) or other regulated environment.
Good working knowledge in navigation and use of the Windows operating system in a networked environment.
Strong understanding on the use of some Microsoft Office Tools such as: Outlook, Word, Excel, Power Point.
Basic knowledge to read and interpret charts, graphs and tables of information.
Aptitude to learn new software applications.
- While performing the duties of this job, the employee is regularly required to be sitting, walking and use hands and fingers, handle or feel, frequently required to talk or hear, reach with hands and arms, climb or balance, stoop, kneel and crouch.
- Specific vision abilities required by this job include close vision, (vision 20/20 is a plus).
- Ability to use special protection devices for ears and eyes at the same as gloves for hands where deemed necessary.
This job description is not intended to be an exhaustive list of all skills, duties, responsibilities, or qualifications associated with this position. While this list is intended to be an accurate reflection of the current job, the company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change. Employees are held accountable for all duties of position.