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.

• 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 reinfoced by appropriate evidence
• Identify trends and recurring issues and upscale concerns appropriately

• 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

• 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

• 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

• 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

• 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.

• 2+ year of experience in a Quality Assurance role, plus additional prior experience in a fast-paced operational environment (demonstrating strong documentation practices, issue escalation, and cross-functional coordination; regulated manufacturing experience (OTC drug, cosmetic, dietary supplement, pharmaceuticals or similar) is also desired
• Bachelor's degree in biology, chemistry, microbiology, or a related science field, preferred
• Experience supporting deviation/nonconformance and CAPA workflows, including entering records, maintaining documentation, tracking timelines, and coordinating follow-up actions
• Experience supporting investigations through evidence gathering, document review, timeline development, and clear, objective documentation (with escalation to QA leadership as required)
• Familiarity with regulated documentation expectations (GDP) and quality/compliance principles; ability to learn and apply site-specific GMP/GDP procedures and risk assessment tools quickly
• Experience using electronic systems for quality event tracking and reporting (e.g., QMS platforms, ERP systems, and documentation databases) required
• Experience supporting complaint documentation/tracking and basic trend summaries preferred

• Strong working knowledge of GDP/GMP documentation expectations for deviations, NCMs, CAPAs, and complaint records
• Excellent attention to detail and ability to produce clear, accurate, objective documentation suitable for audit/inspection review
• Strong organizational skills; able to manage multiple investigations and action items simultaneously while maintaining timelines and follow-through
• Ability to apply risk-based thinking…