QA Product & Complaint Specialist — Onsite NY

RXinsider LTD.; Hauppauge (NY); On-site; USD 66,000 - 86,000; Full time

Benefits offered by this job

401(k) matching

Health insurance (medical/dental/vison

Health savings account (HSA)

Flexible spending account (FSA)

Paid time off (PTO)

Paid holidays

Short-term disability (STD)

Long-term disability (LTD)

Parental leave

Paid family leave

Employee discounts

Job summary

Cipla is seeking a QA Associate Product & Complaint Specialist to investigate, document, and process customer complaints for drug-device products. You will ensure compliance with cGMP, assist in QMS activities, and support continuous improvement.

This onsite role in Hauppauge NY partners with cross-functional teams to maintain high-quality standards. The ideal candidate has a bachelor’s in a scientific field, at least 2 years in a regulated environment, strong technical writing skills, and

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• Minimum 2 years of experience in a regulated life sciences environment preferred.
• Familiarity with ISO 13485, FDA cGMPs, or laboratory safety.
• Strong technical writing and data analysis skills.

Responsibilities

• Sample Coordination: coordinate receipt of returned complaint samples with pharmacy personnel and field reps.
• Logistics & Tracking: manage shipping/logistics of samples to labs or vendors as needed.
• Sample Preparation: label, log, and track physical complaint samples on arrival.
• Technical Evaluation: visually inspect returned samples for damage and device functionality.
• Investigation Documentation: thoroughly document inspection details and findings.
• QMS Management: assist with change controls, CAPAs, deviations, OOS, and market complaints.
• SOP Maintenance: draft/revise SOPs related to quality assurance.
• Risk & Metrics Support: assist with FMECA and QMR data preparation.
• Data Trending: generate trends for market complaints, deviations, CAPAs, and EM.
• cGMP Compliance: maintain strict cGMP across procedures.
• Continuous Improvement: assist in improving compliance system operations and user experience.
• Audit Readiness: participate in internal audits and regulatory inspections.
• Training Support: help deliver improved training programs.

Skills

Technical writing

Attention to detail

Regulatory knowledge

Willingness to learn

Education

Bachelor’s degree in science/technical field

Tools

Excel

Word

Job description

Cipla is seeking a QA Associate Product & Complaint Specialist to investigate, document, and process customer complaints for drug-device products. You will ensure compliance with cGMP, assist in QMS activities, and support continuous improvement.

This onsite role in Hauppauge NY partners with cross-functional teams to maintain high-quality standards. The ideal candidate has a bachelor’s in a scientific field, at least 2 years in a regulated environment, strong technical writing skills, and