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.