QA Associate - Customer Complaints

Cipla•Hauppauge, NY

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Biomedical Engineering, Nursing, or Pharmacy).
Minimum 2 years of experience.
Familiarity with basic quality concepts (e.g., ISO 13485, FDA cGMPs, or general laboratory safety) gained through coursework or internships.
Strong technical writing skills.
High attention to visual detail.
Proficiency with standard office software (Excel, Word).
Strong willingness to learn complex regulatory frameworks.

Nice To Haves

Prior internships or co-ops within a regulated life sciences environment (biotech, pharma, or medical devices) are highly preferred.

Responsibilities

Communicate directly with pharmacy personnel and field representatives to coordinate the receipt of returned complaint samples.
Manage the shipping and logistics of sending complaint samples to external laboratories or international component vendors when required.
Execute the secure labeling, logging, and tracking of physical complaint samples upon arrival.
Perform visual inspections of returned samples to check for physical damage, defects, and overall device functionality.
Thoroughly document inspection details and technical findings in complaint investigation forms.
Assist in handling various Quality Management System (QMS) elements, including change controls, CAPAs, deviations, Out-of-Specification (OOS) results, and market complaints.
Draft, review, and revise Standard Operating Procedures (SOPs) related to Quality Assurance.
Participate in Failure Modes, Effects, and Criticality Analysis (FMECA) and assist in preparing Quality Management Review (QMR) data.
Generate data trends for market complaints, deviations, CAPAs, purified water systems, and environmental monitoring (EM).
Maintain strict compliance with current Good Manufacturing Practices (cGMP) across all procedures.
Identify and help implement business process solutions to improve compliance system operations, efficiencies, and the user experience.
Actively participate in internal audits, regulatory inspections, and compliance-related activities.
Collaborate with team members to identify training needs, assist with new hire orientations, and help deliver improved training programs.