Quality Investigations Coordinator

W. S. Badger; Gilsum (NH); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary &

Paid Time Off (Vacation, Sick &

Family Leave (Maternity, Paternity)

Short Term & Long Term Disability

Wellness Resources

Job summary

The Investigations Coordinator at W.S. Badger, based in New Hampshire, supports the Quality Unit by driving complaint investigations, CAPA activities, and deviations within the QMS.

You will collaborate across QA, Operations, and QC to ensure timely closure of records and accurate documentation in GDP-compliant formats. Responsibilities include managing the complaint lifecycle, supporting root cause analysis with tools like 5 Whys and Fishbone, and assisting with sampling and inspection

Qualifications

• 1+ year of experience in a Quality Assurance or related role in a regulated environment preferred
• High school diploma or equivalent; bachelor's degree preferred
• Experience supporting investigations through evidence gathering, document review, and clear, objective documentation

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

Skills

Attention to detail

Organization

Communication

MS Office

QMS tools

Education

High school diploma or equivalent

Bachelor's degree in biology/chemistry/microbiology or related science

Tools

QMS platforms/ERP systems

Microsoft Office

Job description

The Investigations Coordinator at W.S. Badger, based in New Hampshire, supports the Quality Unit by driving complaint investigations, CAPA activities, and deviations within the QMS.

You will collaborate across QA, Operations, and QC to ensure timely closure of records and accurate documentation in GDP-compliant formats. Responsibilities include managing the complaint lifecycle, supporting root cause analysis with tools like 5 Whys and Fishbone, and assisting with sampling and inspection