Quality Compliance Associate – Complaints / Return & Retain Examination Support

This role involves complaint intake, data entry, reconciliation, drug product shipping oversight, and coordination with contract manufacturing organizations (CMOs) and third-party partners. My name is Mahalakshmi, and I m reaching out from Intellectt Inc. regarding an exciting contract opportunity Quality Compliance Associate Complaints / Return & Retain Examination Support based Rensselaer, NY Onsite, at one of our prestigious clients.

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I m reaching out from Intellectt Inc. regarding an exciting contract opportunity Quality Compliance Associate Complaints / Return & Retain Examination Support based Rensselaer, NY Onsite, at one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

mahalakshmi.n@intellectt.com

OR +1 (732) 737 8381

Job Title: Quality Compliance Associate Complaints / Return & Retain Examination Support
Location: Rensselaer, NY Onsite
Pay Rate: $35 $40/hour on W2
Experience: 3+ years

Position Overview

We are seeking a Quality Compliance Associate to support product complaint handling and quality compliance activities within a pharmaceutical manufacturing environment. This role involves complaint intake, data entry, reconciliation, drug product shipping oversight, and coordination with contract manufacturing organizations (CMOs) and third-party partners.

Key Responsibilities

• Receive, document, and enter product complaints into the complaint management system.
• Maintain accurate complaint records and perform complaint reconciliation.
• Coordinate with CMOs and external partners to request investigations, supporting documentation, and status updates.
• Support return and retain examination activities related to product complaints.
• Provide quality oversight of drug product shipments, including reviewing shipment paperwork and performing QA verification.
• Review batch disposition and sampling data for accuracy and completeness.
• Prepare deviation reports and supporting documentation for quality review.
• Use LIMS, electronic Quality Management Systems (eQMS), and complaint management systems to maintain and review quality records.
• Ensure activities and documentation comply with GMP requirements and applicable pharmaceutical and medical device regulations.

Required Qualifications

• 3 - 5 years of relevant experience in quality compliance, quality assurance, or complaint handling within a pharmaceutical manufacturing environment.
• Strong knowledge of Good Manufacturing Practices (GMP).
• Understanding of pharmaceutical and medical device regulatory requirements.
• Experience with complaint intake, documentation, data entry, and reconciliation.
• Experience supporting drug product shipping oversight and reviewing quality documentation.
• Experience preparing deviation reports.
• Familiarity with LIMS, eQMS, and complaint management systems.
• Strong written communication skills and experience coordinating with CMOs and third-party vendors.
• Strong attention to detail, organization, and record accuracy.
• Ability to work onsite in Rensselaer, NY.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws
Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com