Deviations Specialist

Essential Responsibilities

• Deviation & Investigation Management: Own and manage the end-to-end deviation lifecycle, including initiation, triage, investigation, documentation, and closure
• Aid in the timely, thorough, and compliant investigation of deviations in accordance with internal procedures and regulatory expectations
• Lead root cause analysis using structured tools (e.g., 5 Whys, Fishbone, fault tree analysis)
• 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 aid in 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

• 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

Other Tasks

• Serve as a member of the audit team during FDA inspections
• Back up QA team as necessary

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

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer
• Able to lift to 15 pounds at times

Pay

Starting at $28.00 an hour; salary is commensurate to experience.

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