Position Summary:

Support continuous improvements to Harvard Bioscience products, services, processes, and procedures by taking full responsibility (owning) of our documentation control system.

Essential Duties and Responsibilities:

• Own the methodology and process for documentation control, including the pursuit of standardization.
• Own the change order work flow process. This includes establishing and documenting content requirements for various types of change orders, confirming proper and complete content and accurate rendering of changes in the change order and supporting documentation prior to routing, and managing the change order thru the release process.
• Own the change order approval process including understanding approval responsibilities of functional reviewers, identifying the appropriate approvers, and setting and managing the correct change order workflow.
• Maintain the change order approval matrix.
• Preserve the integrity of the change order process by ensuring compliance with the documented processes. Identify and correct gaps or ambiguities in documented processes.
• Use configurator tool to port meta data between Agile and JDE system.
• Implement and improve documentation to optimize processes and improve efficiency for routine tasks performed across the organization.
• Perform tasks in Agile for other team members to improve overall department efficiency.
• Work with IT team to recommend and implement system improvements.
• Help identify, capture and document processes that need to be improved, are not documented but are essential, or are outdated.
• Develop, implement, and maintain training materials for users of Agile system and perform training. Train new employees how to properly do change orders.
• Recommend and implement improvements to quality system process and documents.
• Maintain standards library.
• Participate in customer, quality, or regulatory audits.
• May assist with maintaining and updating design history files, Declarations of Conformity and technical files.
• May assist with documentation and filing of intellectual property.

Required Skills and Abilities:

• HS Diploma with 5 years experience, 2 year degree with 3 year experience or 4 year degree with 2 years experience.
• Highly self-motivated with strong desire to work as a team, learn, excel and implement system wide improvements.
• Highly organized and detailed oriented.
• Excellent proof-reading skills.
• Excellent communication and collaboration skills and a positive team player.
• Experience with Oracle Agile PLM applications.
• Experience with JDE ERP applications.
• Proficiency with MS office applications (word, excel, Visio)

Desired Skills and Abilities (or ability & desire to learn):

• Understanding of Good Laboratory Practices (GLP) and OECD compliance.
• Familiarity with engineering drawings and redlines.
• Quality assurance background.

Travel:

Minimal travel, if any.

Position Type/Expected Hours of Work:

This is a full-time position. Employees are a provided with flexibility depending on the needs of the business.