Document Control Specialist

§ Maintains and manages the update, review, release, and storage, of all controlled documents to build, strengthen and maintain QMS. Documents may include, but are not limited to policies, procedures, work instructions, forms, standards, templates, and tools.

§  Manage the document and change control process to include working directly with authors, reviewers, and approvers to facilitate document and change order workflow; assisting with document formatting; ensuring proper document organization; ensuring required metadata and other applicable data inputs for compliance are provided; and tracking and trending of open tasks to facilitate timely turn-around.

§  Serve as the QMS documentation SME, providing guidance to colleagues regarding the requirements, adequacy and compliance status of documentation and records related to QMS

§  Lead cross functional teams of process owners, content experts and functional area subject matter experts, through document harmonization, coordinating multiple cross-functional change requests.

§  Communicate document changes and administer notifications to employees.

§  Evaluate processes for compliance with quality requirements/changing business needs and facilitate and/or participate in improvements.

§  Manage master project folder templates and assist teams in project folder compliance audits.

§  Supports QA Manager in site compliance efforts for ISO 9001:2015.

§  Training of Management, and Employees, in the requirements of ISO 9001:2015.

§  Prepare and conduct training of Internal Auditors with continuous support throughout the internal audit program.

§  Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.

§  Participate in quality audits (and lead a team of quality auditors, when needed).

§  Identify processes, situations, etc., where organization is meeting requirements, as well as identify opportunities for improvement.

§  Assist with follow-up audits, OFI and Corrective Action resolution.

§  Support all facets of external audits including certification and surveillance audits.

§  Assist Quality Manager in the preparation for, conduct of, and follow-up activities associated with site visits from customers or registrar agencies.

§  Supports the Quality Manager for all Quality and Regulatory plans, actions, implementation and upskilling as the business grows.

§  Assist Continuous Improvement Specialists as needed, including management of CI intranet page and LeanDNA administration.

§  Facilitates various Lean tools within the organization including: Process Mapping and other visual management techniques.

§  Assist with the administration of the Knowledge Base database.

§  Assist with the corrective and preventive action (CAPA) processes.

 

§  Bachelor's Degree preferred, Associate's Degree required.

§  1-3 years of working experience in Document Control or related role building and maintaining QMS.

§  Experience auditing to ISO 9001:2015 or similar standard

§  Can write accurate technical documents with, clarity, concision, and consistence. Is able to produce documents that serve the needs of appropriate audiences, as well as edit documents created by others to ensure overall quality and professionalism.

§  Can confidently communicate and collaborate through a variety of mediums with a variety of employees, ranging in function and personality.  Is able to collect feedback from varying stakeholders and integrate and/or moderate ideas in order to produce quality documents and document management.

§  Possesses the ability to identify and rectify inconsistencies, gaps, or other areas for improvement in all internal documents.  Attention to detail must be executed in regard to content, formatting, grammatical accuracy, and document deliverables.

§  Ability to stay on task while ensuring a variety of activities can be completed within deadlines.

§  Able to serve as a technical resource in regard to document standards and functionality.  Must be able to quickly learn technical terms well enough to write with and about them.  Must also be able to work through problems that do not have a clear answer.

 

§  Influencing