Deviations Specialist

Location: Bradford

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 reinfoced 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.

Requirements

Education & 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.

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…