Deviation Coordinator

Reports To: Quality Manager

Position Type: Permanent, Full-Time, Non-Exempt

Location: Fully on Site

The Deviation Coordinator supports the Badger Mission and Principles as a member of the Quality Unit. They are responsible for supporting the deviation management system through the entry, review, and investigations of deviations, NCMs and OOS. They also support the full quality system as a collaborative member of the Quality Unit. This role operates under the direct supervision of the Quality Manager.

Essential Responsibilities:

Deviations Management and Investigation Coordination

·         Enter Deviations and NCM’s, as needed

·         Act as the primary initial reviewer of Deviations and NCM's, determining initial risk level of the deviation or NCM

·         Conduct and document all deviation and non-conformance investigations, identifying root cause and corrective actions, with support and oversight from the Deviations Manager

·         Conduct and document OOS phase II investigation, when lab error is not found as the root cause, with support from the Deviations Manager and QC Supervisor

·         Work with Deviations Manager to support CAPA investigations and documentation

·         Support Deviation Manager in completing risk assessments as assigned

·         Ensure investigations are fully documented and assigned to Deviations Manager for Final Approval, and to the QA Project Manager for Implementation of corrective and preventive actions

·         Gather data for Deviations, NCM, OOS and CAPA’s for Annual Product Review, and trending

Other Tasks

·         Back up QA Core Daily Functions

·         Support Process Validation monitoring, as needed

·         Serve as member of the audit team during FDA inspections

Requirements

·         1-2 years of Quality Assurance Experience preferred

·         Excellent written communication and attention to detail required, problem solving skills preferred

·         Experience with Microsoft Office programs, inventory control programs, and QMS programs is preferred

·         Excellent organization and systems thinking

PHYSICAL REQUIREMENTS

Employee must be able to perform these essential functions of the job with or without reasonable accommodations

Benefits

• Generous Paid Time off
• Free Organic Daily Lunches
• Volunteer Paid Time Off
• 401k with Employer Match
• Health Care Plan (Medical, Dental & Vision)
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Wellness Resources
• Employee discount