QA Product & Complaint Specialist

Cipla; Hauppauge, Northern (NY, KY); Hybrid; USD 66,000 - 86,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

HSA

FSA

PTO - vacation/sick/flex time

Paid holidays

STD

LTD

Parental leave

Family leave

Employee discounts

Job summary

Cipla is seeking a QA Associate Product & Complaint Specialist in Hauppauge, NY, to investigate and document customer complaints for drug-device products, ensuring compliance with global regulations. The role covers evaluation of drug and delivery device for failures, ADRs, or user errors.

Responsibilities include sample coordination, logistics, documentation, and QMS support, with emphasis on cGMP adherence and continuous process improvement.

Qualifications

• Strong technical writing skills essential.
• High attention to visual detail required.
• Proficiency with Excel and Word.
• Willingness to learn complex regulatory frameworks.

Responsibilities

• Coordinate sample receipt with pharmacy personnel and field reps.
• Manage shipping/logistics of samples to labs or vendors.
• Label, log, and track physical complaint samples on arrival.
• Perform visual inspection of returned samples for damage and device function.
• Document investigation details in complaint forms.
• Support QMS elements: CAPAs, deviations, OOS, market complaints.
• Draft/revise SOPs related to Quality Assurance.
• Support FMECA and QMR data preparation.
• Generate data trends for market complaints and environmental monitoring.

Skills

Technical writing

Attention to detail

Excel

Word

Regulatory frameworks

Education

Bachelor’s degree in science/technical discipline

Job description

Cipla is seeking a QA Associate Product & Complaint Specialist in Hauppauge, NY, to investigate and document customer complaints for drug-device products, ensuring compliance with global regulations. The role covers evaluation of drug and delivery device for failures, ADRs, or user errors.

Responsibilities include sample coordination, logistics, documentation, and QMS support, with emphasis on cGMP adherence and continuous process improvement.