Sr. QA Product Complaint Investigator-REMOTE
The Judge Group
Product, Quality Assurance
Remote
Posted on May 15, 2026
Our client is currently seeking a Sr. QA Product Complaint Investigator-REMOTE
Triage incoming
complaints and engage with call center as necessary
Initiate customer complaints, investigations, and
supplier corrective action requests
Manage and document
thorough and accurate complaint records while ensuring they are processed
in a uniform and timely manner.
Ensure complaint records
and applicable complaint handling documents are compliant with Good
Documentation Practices (GDP).
Follow-up with
complainants to gather information required for robust complaint handling
activities
Maintain professional
communications with internal and external customers to gain insight into
each complaint event and product sample return.
Facilitate complaint
product returns utilizing the Moderna logistics program and engaging with
the logistics team.
Ensure appropriate root cause analysis is completed by
contract partners and subject matter experts
Monitor compliant investigation CAPA’s, ensure
effectiveness and adherence to commitments
Review and prepare
customer communication (response letters, acknowledgement letters)
Will be responsible for initiating product complaints and conduct compliant investigations from start to completion.
Job Duties:
• Create and maintain data tracking systems that govern the complaint program.
• Initiate complaints and manage compliant investigations from start to completion.
• Review and approve complaint investigations and ensure compliance with internal policies/procedures and regulatory requirements and guidance.
• Maintain complaint data, review data for trends and ensure high risk / systemic issues are identified and escalated promptly
• Monitor compliant investigation CAPA's, ensure effectiveness and adherence to timelines / customer commitments.
Job Qualifications:
• 5+ years of Quality/Product Investigation experience in biotech or pharmaceutical industry Required.
• Demonstrated skill in facilitating complex investigations from initiation to completion.
Must have strong investigation skills
• Knowledge of Root Cause Analysis (RCA) process.
Triage incoming
complaints and engage with call center as necessary
Initiate customer complaints, investigations, and
supplier corrective action requests
Manage and document
thorough and accurate complaint records while ensuring they are processed
in a uniform and timely manner.
Ensure complaint records
and applicable complaint handling documents are compliant with Good
Documentation Practices (GDP).
Follow-up with
complainants to gather information required for robust complaint handling
activities
Maintain professional
communications with internal and external customers to gain insight into
each complaint event and product sample return.
Facilitate complaint
product returns utilizing the Moderna logistics program and engaging with
the logistics team.
Ensure appropriate root cause analysis is completed by
contract partners and subject matter experts
Monitor compliant investigation CAPA’s, ensure
effectiveness and adherence to commitments
Review and prepare
customer communication (response letters, acknowledgement letters)
Will be responsible for initiating product complaints and conduct compliant investigations from start to completion.
Job Duties:
• Create and maintain data tracking systems that govern the complaint program.
• Initiate complaints and manage compliant investigations from start to completion.
• Review and approve complaint investigations and ensure compliance with internal policies/procedures and regulatory requirements and guidance.
• Maintain complaint data, review data for trends and ensure high risk / systemic issues are identified and escalated promptly
• Monitor compliant investigation CAPA's, ensure effectiveness and adherence to timelines / customer commitments.
Job Qualifications:
• 5+ years of Quality/Product Investigation experience in biotech or pharmaceutical industry Required.
• Demonstrated skill in facilitating complex investigations from initiation to completion.
Must have strong investigation skills
• Knowledge of Root Cause Analysis (RCA) process.
• Experience working on Supplier Corrective Action Reports (SCAR)Preferred
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development.
• Excellent communication and executive presence (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development.
• Excellent communication and executive presence (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
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