Deviations Specialist

About the role

The Deviations Specialist supports the Badger Mission and Principles as a member of the Quality Unit. They are responsible for 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.

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
  • Aid in 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 aid 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
  • Aid in updating SOPs, templates, and guidance documents related to deviations and investigations
• Complaints:
  • Initiate and disposition of complaint investigations, identifying complaints that require urgent attention
  • Review and track complaints in the QMS
  • Create annual complaints reports with trend analysis
  • Coordinate with Customer Service to ensure complaints are reported in accordance with regulatory requirements
• Other Tasks:
  • Serve as member of the audit team during FDA inspections
  • Back up QA team as necessary
  • Other duties, as required

Requirements

• Education & Experience:
  • 2+ years 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

Skills

• 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 using established tools/templates, and escalate higher-risk issues to the QA Supervisor/Quality Manager promptly.
• Effective communicator able to coordinate with Production, QC, Warehouse, and other stakeholders to collect evidence, clarify events, and drive closure.
• Proficient in Microsoft Office; comfortable working in QMS platforms, ERP systems (e.g., Syspro or equivalent), and data tracking tools.
• Works well with routine structure and deadlines; able to balance desk-based documentation with time on the production floor as needed.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retailment Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Wellness Resources