Deviations Specialist

W.S. Badger Company•Gilsum, NH

1d•Onsite

About The Position

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

Requirements

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.
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.
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.

Nice To Haves

Bachelor's degree in biology, chemistry, microbiology, or a related science field, preferred.
Experience supporting complaint documentation/tracking and basic trend summaries preferred.

Responsibilities

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 escalate 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