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 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 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.

Physical Requirements:

Physical requirements for the job include but are not limited to prolonged periods sitting at a desk and working on a computer. Must be able to lift to 15 pounds at times. Employees should be able to perform the essential functions of the job with or without reasonable accommodation.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement 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