QA Associate - Customer Complaints

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

• 401(k) savings plan and matching
• health insurance - medical/dental/vision
• health savings account (HSA)
• flexible spending account (FSA)
• paid time off (PTO) - vacation/sick/flex time
• paid holidays
• short-term disability (STD)
• long-term disability (LTD)
• parental leave
• paid and unpaid family leave
• employee discounts
• other benefits

The Combination Product Complaint Specialist investigates, processes, and documents customer complaints for integrated drug-device products. This role ensures compliance with global regulations by evaluating both the drug component and the delivery device for technical failures, adverse drug reactions, or user errors

• Sample Coordination:
  Communicate directly with pharmacy personnel and field representatives to coordinate the receipt of returned complaint samples.
• Logistics & Tracking:
  Manage the shipping and logistics of sending complaint samples to external laboratories or international component vendors when required.
• Sample Preparation:
  Execute the secure labeling, logging, and tracking of physical complaint samples upon arrival.
• Technical Evaluation:
  Perform visual inspections of returned samples to check for physical damage, defects, and overall device functionality.

• Investigation Documentation:
  Thoroughly document inspection details and technical findings in complaint investigation forms.
• QMS Management:
  Assist in handling various Quality Management System (QMS) elements, including change controls, CAPAs, deviations, Out-of-Specification (OOS) results, and market complaints.
• SOP Maintenance:
  Draft, review, and revise Standard Operating Procedures (SOPs) related to Quality Assurance.
• Risk & Metrics Support:
  Participate in Failure Modes, Effects, and Criticality Analysis (FMECA) and assist in preparing Quality Management Review (QMR) data.
• Data Trending:
  Generate data trends for market complaints, deviations, CAPAs, purified water systems, and environmental monitoring (EM).

• cGMP Compliance:
  Maintain strict compliance with current Good Manufacturing Practices (cGMP) across all procedures.
• Continuous Improvement:
  Identify and help implement business process solutions to improve compliance system operations, efficiencies, and the user experience.
• Audit Readiness:
  Actively participate in internal audits, regulatory inspections, and compliance-related activities.
• Training Support:
  Collaborate with team members to identify training needs, assist with new hire orientations, and help deliver improved training programs.

• Educational
  
  Qualification:
  
  Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biomedical Engineering, Nursing, or Pharmacy).
• Work Experience:
  
  minimum 2 years of experience. Prior internships or co-ops within a regulated life sciences environment (biotech, pharma, or medical devices) are highly preferred.
• Basic Knowledge:
  Familiarity with…