QA Complaints Investigator - GxP & Regulatory

Redbock - an NES Fircroft company; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a QA Specialist, Complaints to manage and investigate product quality complaints in alignment with QA, Regulatory Affairs, Manufacturing, Supply Chain, Medical Affairs and Pharmacovigilance. The role ensures compliance with FDA, EU, ICH and GMP standards while driving continuous improvement.

You will review and document complaints, perform root cause analysis, assess product impact, and track trends.

Qualifications

• Bachelor’s degree in Life Sciences or related field plus 3+ years in QA within pharma/biotech/medical device.
• Experience managing product complaints in a regulated GxP environment.
• Familiarity with FDA QSR, ICH guidelines, GMP requirements.
• Experience with CAPA, deviations, and change controls.

Responsibilities

• Review, document, and process customer and product quality complaints per procedures and regulations.
• Conduct complaint investigations including root cause analysis and product impact assessment.
• Collaborate with cross-functional teams to gather information for evaluations.
• Determine reportability and escalate potential quality issues.
• Identify trends to support risk assessments and quality improvements.
• Ensure complaint records are complete and closed within timelines.
• Support CAPA activities arising from investigations.
• Assist with inspections, internal audits, and quality system assessments.
• Maintain compliance with FDA, EU, ICH, and other regulatory requirements.
• Generate complaint metrics and dashboards for management review.
• Participate in SOP development and training related to complaint handling.

Skills

Organizational skills

Communication skills

Problem-solving skills

MS Office

Quality management software

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or related field

Tools

TrackWise

Veeva Quality

MasterControl

ComplianceWire

Job description

Redbock - an NES Fircroft company is seeking a QA Specialist, Complaints to manage and investigate product quality complaints in alignment with QA, Regulatory Affairs, Manufacturing, Supply Chain, Medical Affairs and Pharmacovigilance. The role ensures compliance with FDA, EU, ICH and GMP standards while driving continuous improvement.

You will review and document complaints, perform root cause analysis, assess product impact, and track trends.