QA Associate - Customer Complaints

About the role

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. Position is located at 7 Oser Avenue, Hauppauge, NY (Onsite). Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines, trusted by healthcare professionals and patients across geographies.

Responsibilities

• 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.

Qualifications

• 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 basic quality concepts (e.g., ISO 13485, FDA cGMPs, or general laboratory safety) gained through coursework or internships.
• Core Skills: Strong technical writing skills, high attention to visual detail, proficiency with standard office software (Excel, Word), and a strong willingness to learn complex regulatory frameworks.

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

Pay

$66,300 - $86,000

Schedule

General Shift: 9:00AM- 5:30PM