Quality Assurance

Job Description

• Collecting all supporting documentation from Process Owners/SMEs to support the Change Request, including but not limited to supplier supplied documentation and in-house data.
• Documenting the Change Proposal per LCD procedures
• Route all changes for impact assessments and signatures
• Logging and Issuance of Change requests to impacted areas for completion of tasks via the document control process
• Performing follow-up activities with Process Owners/SMEs to ensure all implementation tasks are completed and documented in the Change Management System by Tracking of task completion to ensure closure of change required deliverables
• Performing records retention activities to ensure Change Management records are readily retrievable
• Drafting and routing of Customer Notifications as required
• Generating task related metrics and presenting to project managers/leadership

• Bachelor’s Degree in Science or Engineering
• Experience with change management
• ISO, Pharma or Med device as well is preferred
• Material purchasing exposure,
• Project management skills.
• Experience with QMS databases such as Agile and Trackwise preferred.

• Knowledge of the most recent version of ISO9001. FDA GMP a plus
• Skilled at reporting metrics showing performance and trending
• Ability to manage numerous priorities and activities in parallel
• Excellent verbal and written communication skills; ability to write reports required.

Excellent organizational skills and be detail oriented

Qualifications

ISO, Pharma or Med device as well is preferred.

Experience with QMS databases such as Agile and Trackwise preferred.

Additional Information