- Oversee the routing and approval process working with various corporate partner departments.
- Develop and propose change control processes for document storage, retention, and compliance.
- Disseminate new or updated procedures and standards to all Kenco departments and sites.
- Regularly perform document archival and retention activities.
- Provide guidance and assist site level members with document control and other QMS related activities as needed.
- Serve as the QMS module subject matter expert and monitor site level metrics while working with sites to improve performance.
- Under broad supervision, conduct non-routine analysis such as retention scheduling, records classification, workflow, and process analysis and more as required by business needs.
- Perform mapping within the QMS module, identifying bottlenecks or redundancies and work with sites to develop streamlined procedures.
- Assist corporate departments and sites on the QMS training module implementation.
- Interpret and analyze regulatory requirements, providing guidance to ensure Kenco practices align with regulations.
- Identify opportunities for improvement to the QMS and assist sites in implementing improvement projects.
- Identify training needs and organize training interventions to meet quality standards across corporate and multiple sites.
- Assist start-up accounts in the implementation of their quality management system and onboard all personnel to the QMS.
- Collect and compile statistical quality data and analyze to identify areas for improvement to the quality management system across corporate and multiple sites.
- Other applicable duties as required.
- A bachelor's degree in engineering, business, or related field required or equivalent years of experience required. Equivalent years of experience is defined as one year of professional experience for each year of college requested.
- 4-6 years' experience in a document control/quality assurance role in food, pharma, or other highly regulated field preferred.
- Knowledge of Qualityze software or similar document control software required.
- Knowledge and experience with ISO 9001:2015 or applicable standard for the position industry required.
- Strong technical writing skills preferred.
- Ability to facilitate learning through multiple different methods and tools.
- Strong written and verbal communication skills.
- Strong attention to detail in a fast paced environment with competing priorities.
- Business Acumen - Knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization.
- Communicate for Impact - Devoting the time and resources necessary to communicate the strategic vision, direction, priorities, and progress of the team for which you are responsible.
- Influencing Others - Can quickly find common ground and can solve problems for the good of the organization with a minimal amount of noise. Authentically gains trust and support of peers.
- Managing Transitions / Change Management - Effectively plans, manages and communicates changes in processes with appropriate stakeholders.
- Strategic Agility - Enable Kenco to remain competitive by adjusting and adapting to innovative ideas necessary to support Kenco's long term organizational strategy.
- This position is expected to travel approximately 25% - 50%.
- A passport is not required, but recommended.
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Document Control Specialist - Chattanooga, United States - Kenco Group
Description
About the Position
The Document Control Specialist will assist corporate and site-level designees in the continuous improvement of the site quality management system (QMS) and ensure that processes and procedures are developed in line with applicable standards and customer requirements. The Document Control Specialist will serve as a corporate leader in mentoring and assisting corporate and site quality designees in the development of the QMS and serve as an educator to the existing operational personnel on quality management system requirements. The role will also support and assess the implementation of the Kenco Operating System as it relates to quality assurance and will travel to sites to aid in their configuration.
Functions
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)