QA Specialist, Complaints

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

The QA Specialist, Complaints is responsible for managing and investigating product quality complaints to ensure compliance with applicable regulatory requirements and company quality standards. This role partners closely with Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, Medical Affairs, and Pharmacovigilance teams to assess, document, investigate, and resolve complaints in a timely manner while supporting continuous improvement initiatives.

Key Responsibilities

• Review, document, and process customer, product quality, and compliance-related complaints in accordance with company procedures and regulatory requirements.
• Conduct complaint investigations, including root cause analysis and assessment of product impact.
• Collaborate with cross-functional teams to gather information required for complaint evaluations and investigations.
• Determine reportability requirements and escalate potential product quality issues as appropriate.
• Identify and track trends in complaints to support risk assessments and quality improvement activities.
• Ensure complaint records are complete, accurate, and closed within established timelines.
• Support corrective and preventive action (CAPA) activities arising from complaint investigations.
• Assist with health authority inspections, internal audits, and quality system assessments.
• Maintain compliance with FDA, EU, ICH, and other applicable regulatory requirements.
• Generate complaint metrics, trend reports, and quality system dashboards for management review.
• Participate in SOP development, revision, and employee training activities related to complaint handling processes.

Qualifications

Required

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or related field.
• 3+ years of Quality Assurance experience within the pharmaceutical, biotechnology, medical device, or combination product industry.
• Experience managing product complaints and conducting investigations within a regulated GxP environment.
• Knowledge of FDA Quality System Regulations (21 CFR Part 210, 211, 820), ICH guidelines, and GMP requirements.
• Experience with quality management systems, CAPA, deviations, and change controls.
• Strong organizational, communication, and problem-solving skills.
• Proficiency with quality management software and Microsoft Office applications.

Preferred

• Experience in a biotech or small pharmaceutical company environment.
• Knowledge of complaint handling systems such as TrackWise, Veeva Quality, MasterControl, or ComplianceWire.
• ASQ Certified Quality Auditor (CQA) or related quality certification.
• Experience supporting inspections and regulatory audits.