Investigations Coordinator

Job Description:

The Investigations Coordinator supports the Badger Mission and Principles as a member of the Quality Unit. They are responsible for supporting investigation activities within the QMS, including deviations, non-conformances, out-of-specification (OOS) events, CAPA, and complaints. They also support the full quality system as a collaborative member of the Quality Unit.

Essential Responsibilities

Complaints

• Own and manage the complaint lifecycle, including intake, investigation, documentation, and closure
• Ensure complaint investigations are completed in a timely, thorough, and compliant manner in accordance with internal procedures and regulatory expectations
• Initiation and disposition of complaint investigations, identifying complaints that require urgent attention
• Entry, 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 complaint reports with trend analysis

Investigation Support

• Partner with the Deviations Specialist to support investigation progress, documentation quality, and timely closure of records
• Support deviation (DEV), non-conformance (NCM), out of specification (OOS), and Corrective and Preventive Actions (CAPA) investigations, including entering records, maintaining documentation, and tracking timelines
• Assist with investigation activities, including evidence gathering, document review, and timeline development
• Work with QA, Operations, and QC to support identification of root cause and proposed CAPAs through interviews and use of structured tools (e.g., 5 Whys, Fishbone) as appropriate
• Support investigation-related sampling and inspection activities, including ANSI-based sampling plans or 100% inspection, as required
• Document inspection and investigation results clearly and accurately in accordance with GDP requirements
• Follow up on assigned actions to support timely closure of investigations
• Support trending and data collection for deviations, complaints, and Annual Product Review, as needed

QA Operations & Backup Support

• Back up QA core daily functions, including batch record review and issuance as needed
• Support internal audits, external audits, and regulatory inspections by providing records and responses
• Assist in updating and reviewing SOPs, templates, and guidance documents related to investigations and quality systems, as needed
• Serve as a collaborative QA partner to Manufacturing, QC, Warehouse, and other departments

Pay range $22.00 - $25.00 an hour; salary is commensurate to experience.

Requirements

Education & Experience

• 1+ year of experience in a Quality Assurance or related role in a regulated environment preferred
• High school diploma or equivalent required; bachelor's degree in biology, chemistry, microbiology, or related science field, preferred
• Experience supporting investigations through evidence gathering, document review, and clear, objective documentation
• Familiarity with GDP and quality/compliance principles; ability to learn and apply site-specific procedures
• Experience using electronic systems for quality event tracking and reporting (e.g., QMS, ERP systems) preferred

Skills

• Excellent attention to detail and ability to produce clear, accurate documentation suitable for audit/inspection review
• Strong organizational skills; able to manage multiple tasks while maintaining timelines and follow-through
• Effective communicator able to work with cross-functional teams to collect information and support investigations
• Proficient in Microsoft Office and comfortable working in QMS platforms, ERP systems, and data tracking tools
• Works well with routine structure and deadlines; able to balance desk-based work 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 up to 15 pounds at times. Employees should be able to perform the essential functions of the job with or without reasonable accommodations.

EEO Statement:

W.S. Badger Company, Inc. is an equal opportunity employer, dedicated to the policy of nondiscrimination in employment on any basis including race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, marital status, hair texture or types, or other non-merit-based factors.

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