Deviations Specialist

Deviations Specialist

The Deviations Specialist supports the Badger Mission and Principles as a member of the Quality Unit. They are responsible day-to-day administration and coordination of the deviation management workflow within the QMS, under QA Supervisor direction. They also help the full quality system as a collaborative member of the Quality Unit.

Essential Responsibilities:

Deviation & Investigation Management:

• Own and manage the end-to-end deviation lifecycle, including initiation, triage, investigation, documentation, and closure
• Ensure deviations are investigated in a timely, thorough, and compliant manner in accordance with internal procedures and regulatory expectations
• Assist and, when appropriate, lead root cause analysis using structured tools (e.g., 5 Whys, Fishbone, fault tree analysis)
• Ensure investigations are scientifically sound, risk-based, and reinforced by appropriate evidence
• Identify trends and recurring issues and escalate concerns appropriately

CAPA & Continuous Improvement:

• Partner with QA and functional teams to ensure effective CAPA development, implementation, and verification
• Assess CAPA effectiveness and aide with effectiveness checks
• Identify opportunities to improve investigation quality, documentation consistency, and system performance

Cross-Functional Support:

• Serve as a key QA partner to QC, Manufacturing, and other departments during investigations
• Facilitate investigation discussions and align stakeholders on scope, root cause, and corrective actions
• Provide guidance and coaching to staff on deviation documentation and investigation best practices

Documentation & Compliance

• Ensure deviations meet GDP, cGMP, and data integrity requirements
• Maintain accurate and complete records in the electronic QMS (e.g., ETQ)
• Support internal audits, external audits, and regulatory inspections by providing deviation records and responses
• Assist in updating SOPs, templates, and guidance documents related to deviations and investigations

Complaints:

• Initiation and disposition of complaint investigations, identifying complaints that require urgent attention
• Review and tracking of complaints in the QMS
• Weekly reporting and trend analysis of complaints
• Coordinate with Customer Service to ensure complaints are reported in accordance with regulatory requirements
• Create annual complaints reports with trend analysis

Other tasks:

• Serve as member of the audit team during FDA inspections
• Back up QA team as necessary
• Other duties, as required

Pay starting at $28.00 an hour; salary is commensurate to experience.