Investigations Coordinator

W. S. Badger

Gilsum (NH)

On-site

USD 30,000 - 34,000

Full time

8 days ago

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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

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

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

Job Description

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