Deviations Specialist

W.S. Badger Company; Gilsum (NH); On-site; USD 58,000 - 71,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental & Vision)

Retirement Plan (401k, IRA)

Paid Time Off (Vacation, Sick & Public Holidays)

Job summary

W.S. Badger Company in Gilsum, NH is seeking a Deviations Specialist to oversee the quality management system deviation workflow. The role entails managing deviation investigations, ensuring compliance with regulations, and partnering with cross-functional teams.

The ideal candidate will have 2+ years in Quality Assurance, a degree in a science field, and familiarity with regulated documentation practices. Benefits include health care, retirement plans, and paid time off.

Qualifications

• 2+ years of experience in a Quality Assurance role, preferably in regulated manufacturing.
• Experience supporting deviation/nonconformance and CAPA workflows, including documentation and follow-up actions.
• Strong organizational skills and attention to detail for managing investigations.

Responsibilities

• Manage the deviation lifecycle, including initiation, investigation, and closure.
• Partner with QA to develop and implement CAPA.
• Ensure compliance with GDP, cGMP, and data integrity requirements.

Skills

GDP/GMP documentation knowledge

Attention to detail

Organizational skills

Effective communication

Microsoft Office proficiency

Education

Bachelor's degree in biology, chemistry, microbiology, or related field

Tools

QMS platforms

ERP systems

Job description

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 reinforced by appropriate evidence
• Identify trends and recurring issues and elevate concerns appropriately

CAPA & Continuous Improvement:

• Partner with QA and functional teams to ensure effective CAPA development, implementation, and verification
• Assess CAPA effectiveness and assist 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.

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 elevate 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.

• 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