The Document Control Specialist's primary responsibility is to ensure documents and records are managed according to procedure as they move through their lifecycle. Additionally, this individual helps to institute procedure, drive process, and ensure compliance in an FDA and cGMP environment. Document management is a crucial portion of the Quality System and the position requires a high degree of organization and cross-functional interaction with individuals and teams all across Heartland. The role involves a combination of both group project work and the ability to work independently with negligible oversight.
Essential Duties and Key Responsibilities:
- Responsible for managing access to Heartland’s document control software (DocuWare).
- Integrate approved documents into Heartland’s learning management system (Compliance Wire).
- Ensures all documents are reviewed, approved, version controlled, named and structured for ease of access and secure.
- Advocates for paperless options and helps develop tools to move to electronic records.
- Manages the document life-cycle from creation through destruction in compliance with procedure.
- Works cross-functionally with other departments to ensure documents are available and accurate.
- Manages reporting of metrics and performance related to document control & change management.
- Facilitate Management of Change (MOC) and review documentation and lead regular meetings
- Organize and maintain supplier documents
- Assist in the creation of material risk assessments and material specifications
- Maintain documentation for certification programs including Kosher, Halal, Organic, and Non-GMO Project
- Assist in internal Food Safety and Quality Audits
- Participate in Root Cause Analysis and Food Safety Plan Reviews
- Other projects and duties as assigned
- Bachelor’s degree in Food Science, Microbiology or related degree
- 1-5 years’ experience in food manufacturing
- Certification in SQF and HACCP preferred
- Be a critical thinker
- Be a self-starter
- Intermediate computer experience with a mandatory background in Microsoft Excel, Word, & PowerPoint
- Ability to perform detailed investigations and research with little or no guidance
- Ability to communicate effectively, lead meetings and interface with suppliers and 3rd party services
- Must be proficient in the English language