Document Control Coordinator

Who we seek:  A self-motivated individual who can work independently, with minimum supervision, while meeting deadlines, given or self-imposed.  This person would have exceptional communication & organizational skills – must demonstrate the ability to work on or monitor several tasks or projects concurrently, be an effective communicator to collaborate with teams of all disciplines within the company and to present ideas and findings to colleagues and customers.  You should also show enthusiasm towards responsibilities and pride in a job well done. 

Position Summary: The Document Control Coordinator will maintain and improve the company's electronic and paper-based quality management records and quality system documents that comply with FDA regulations.  Review, create, control, store and document Quality documentation for a dietary supplement and food manufacturing environment such as SOPs, logs, forms, manufacturing records, work instructions, good documentation practices and adequacy of reference procedures and part numbers.  Ensure that batch records and SOPs are being followed and completed.

Essential Functions and Responsibilities to ensure the quality and safety of the product will include, but not be limited to:

• Creates and Processes Change Control Reports and Orders, ensuring completion of all required supporting action/documentation prior to final issue.
• Supports Change Control System metrics to allow for monitoring of trends, etc.
• Supports automation of paper-based quality management processes that comply with FDA regulations.
• Maintain a state of compliance, with international quality standards, the Coordinator will work with other departments to maintain the global records systems and change order processes.
• The coordinator will identify process improvements to improve the efficiency and compliance of global documentation and record retention systems.
• Coordinate processes that maintain Master Data integrity of the ERP system.
• Process Change Orders using defined processes – This includes changes to CCR Form, redlines, drawings, manufacturing inspection and assembly procedures, labels, flowcharts, travelers, etc.
• Assist users in assuring that all Change Order packets are accurate and complete.
• Maintain Document Control's Change Control database that collects metrics
• Maintain records databases.
• Communicates any issues back to customers (Change Control Request Originators).
• Draft and coordinate approval for Master Formula documents
  • This will include development of a product dossier for each formula that will include the following documents:
    • Master Formula
    • Raw Material Specifications, including ingredient composition, allergen statements, etc.
  • Enter data into Inventory Management systems, Document Control systems, and other databases.
  • Change Control
    • Assist, as needed, with the initiation of Change Control documents and provide any needed support to other departments during the review and routing processes.
    • Assist, as needed, with the implementation of affected documents, processes, systems, etc., that result from an approved Change Control request.
  • Facilitate the material review process.
  • Scan, and file Quality related documents such as Certificates of Analysis, training records, etc.
  • Conduct needs assessment to determine when information, documents, records, or signatures are missing or in need of review and initiate corrective action.
  • Log review activities, maintain review status, and provide status update reports as needed.
  • Develop, document, or maintain standards, best practices, or system usage procedures.
  • Prepare and record changes to official documents and confirm changes with compliance and management staff.
  • Monitor regulatory activity to maintain compliance with records and document management laws.
  • Assist with SOP management and coordination.
  • Assist with facilitation of the Training Management system, as needed.
  • Adhere to all cGMP’s and good documentation practices.
  • Record quality, operational and production data on specified forms.
  • Provide information or indication of problems to Management or Quality Assurance.
  • Provide support to others in the Quality Department for special projects, external audits, or when others are short staffed.
  • Report to work regularly and on time.
  • Perform duties safely and to report unsafe conditions or actions.
  • Assists in other duties as needed and directed.

Preferred Knowledge, Skills, and Abilities:

• Skilled in monitoring, critical/strategic thinking, analyzing, decision making, active listening, reading comprehension, time management, initiative and follow through.
• Demonstrate attention to detail, problem sensitivity, problem solving, orientation to quality, to customer service and demonstrate the ability to gather information and evaluate it to determine compliance with standards.
• Knowledge of food production processing, cGMP’s, regulatory environments, and document storage.

Disclaimer: Compensation reflective of candidate’s experience. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. The responsibilities, tasks, and duties of the jobholder might differ from those outlined in this job description and other duties, as assigned, may be part of the job.

We Offer: Medical, Dental, Vision, Life, 401K, Paid Holiday, Paid Vacation, Paid Sick Leave, and more!
** Offers are contingent on successful completion of drug screen and background check**