Document Control Specialist

3 weeks ago

Le Mars, United States Wells Enterprise Full time
Job Description

This position manages documents used in the manufacture and control of Well's Enterprises products across all manufacturing facilities and logistics. This is achieved through document creation, editing, publishing, version control, and retention. Controlled documents include, but not limited to: Standard Operating Procedures (SOPs), Standard Work, Paperwork (Forms), Elegance Guides, and Set-Up Guides. Controlled documents are essential to Quality & Food Safety requirements and Employee Safety, regulatory requirements, customer requirements and manufacturing best practices as well as manufacturing consistency and standardization.

ACCOUNTABILITIES:
  • Follows and adheres to the Document Control Request (DCR) process for actual preparation, review and revisions (incorporating necessary changes) of documents, either alone or in conjunction with other departments as necessary for successful execution. Solicits feedback and review of documents to ensure accuracy across all impacted departments.
  • Is a trusted partner for the facilities team to ensure procedures are documented accurately and reviewed by subject matter experts (SMEs). Works cross functionally to ensure appropriate prioritization of requests.
  • Understands similarities and differences between each facility. This is needed to determine universal document creation or when documentation is necessary to be facility specific.
  • Maintains the on-line library to ensure the most recent documents are published and available for use. Provides all metadata on controlled documents to ensure ease of use within Document Library and HCM Learn.
  • Participates on project teams as assigned. Aware of the changes in facility, equipment, product and processes which may impact documented processes. Identifies impacted documents and updates documentation for project implementation.
  • Ensures HCM Learn has the most recent controlled documents for training needs.
  • Develops and maintains relationships with employees, departments, leadership and SMEs which is necessary to obtain and ensure documentation accuracy.
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Qualifications
  • Associates degree in Business, science, technical writing, training or other applicable discipline required. May substitute years of practical experience for formal degree status
  • 3 years previous technical writing experience desired. Secondary education including writing coursework would be a plus. Demonstrated experience with technical manufacturing / control programs required. Previous experience in an FDA / USDA / EPA regulated industry is desired. Demonstrated experience in a medical product, food or nutritional product manufacturing, or QA / laboratory setting is desired.
  • Knowledge - Demonstrated experience with writing instructional and prescriptive documents for use in manufacturing for job task execution. • Demonstrated experience with document format development, and formatting principles • Understanding of manufacturing principles. • Demonstrated experience in project management. • Understanding of Regulatory and Quality Assurance principles
  • Skills - Skilled in the proficient use in Microsoft Office software Familiarity with manufacturing principles, specifically food or nutritional products, and/ or general laboratory operations beneficial. • General ability to understand facility specific processes such as weighing, measuring, mixing, cleaning, sanitization, documentation, process control automation, task sequencing and scheduling. • Good analytical and problem-solving skills; good attention to detail and ability to follow written and oral instructions. • Multi-project/multi-tasking capability. Understanding of task priority and the ability to task sequence accordingly • Ability to read / write English.
  • Abilities - Ability to establish strong relationships throughout the organization. • Ability to work in a collaborative environment. • Ability to communicate clearly and effectively, both orally and in writing, at all levels • Ability to assist internal customers with change management strategies and processes. • Ability to organize and coordinate multiple tasks and to work under time pressure to meet deadlines. • Ability to multi-task and work within aggressive timeframes with minimal supervision. Proven ability to work with highly confidential information

Wells Enterprises is an EEO/AA employer M/F/Vet/Dis

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