Specialist, Document Control

Job Description

Job Description

Updates logs, databases and catalogues of product, manufacturing and regulatory compliance information. Coordinates the review and revision of procedures, specifications and forms. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Assists in compiling regulatory filing documents and maintaining computerized files to support all documentation systems.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and 2 years in a regulated environment

expert in microsoft word, technical writing, working with cross functional

excellent working knowledge of document control management processes and practices

ability to learn new concepts, coach, mentor, or train on new concepts.

Strong interpersonal skills with the ability to use tact and diplomacy.

Effective analytical problem solving, judgement and decision making required.

Proactive nature and flexibility to change gears with little notice.

Good written and oral communication skills

Detail oriented and organized

Additional Job Details :

Specialist, Document Control, Independent contributor

General Summary

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimum supervision. Under minimal supervision administer Device Master Record (DMR), Change Orders and quality records in accordance with corporate documentation procedures and FDA Good Manufacturing Practices (GMP). This includes administering the documentation aspects of engineering change management, responsibility for the accuracy and reliability of the document data bases, and the maintenance of hard copy and electronic DMR files. Provides training and technical support within the document center and to other user groups in the administration of the Product Lifecycle Management system.

Primary Responsibilities

Will administer the DMR, Specifications, Change Orders, Parts and Bills of Material, through the release and distribution processes in accordance with corporate and department documentation procedures and guidelines.

Will interface with document creators and reviewers to evaluate and judge accuracy and completeness of DMR documentation and change paper within corporate procedure and GMP requirements.

Will collaborate with other departments (e.g., design engineering, purchasing, quality, product line support, test engineering, and manufacturing engineering) to ensure necessary requirements will be met for documentation, parts and Bills of Material.

Will provide training and support to team members and stakeholders on PLM and ERP tools.

Will administer current and historical DMR files in accordance with defined filing standards, record retention policies and GMP.

Will support configuration Management process improvement projects and Kaizens.

Will help establish, create, and maintain document center guidelines and procedures.

Will support and enforce data governance policies and procedures to ensure data accuracy, consistency, and compliance with regulations.

Will train users on various systems and processes as needed such as technical support to customers and other department staff in DMR documents and processes in accordance with corporate document procedures and GMP, and in the use of the PLM and change system.

May execute process and technology projects to add / correct / update / maintain required attributes for production, regulatory (UDI, ACE, PMA, MDD etc.), and to product master data tables to support Order to Cash process.

Basic Qualifications

Bachelors Degree is required

3-5 years experience in configuration control, or 5 years experience with a combination of a minimum of 3 years configuration control experience and equivalent production experience

Preferred / Desired Qualifications

Bachelors Degree in Supply Chain, Manufacturing Systems, or Information Management is preferred

3-5 years of related experience in a business environment

Intermediate to advanced knowledge of Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Access)

Proficient task management including prioritization skills

Self-motivated, organized, details oriented, efficient and process oriented

Team player

Strong work ethic

Good written and oral communication skills

Works well under pressure in a dynamic environment

Tactful, exercises independent judgment and discretion

Professional presentation and strong interpersonal communications skills

Strong judgment and time management skills

Ability to independently write, review, and implement work instruction content to support new systems and processes.