Investigations Coordinator

About the role

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.

Responsibilities

• 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
• 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
• 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

Requirements

• 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

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.

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

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

Pay

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