Quality Compliance Associate – Complaints / Return & Retain Examination Support

Job Title: Quality Compliance Associate Complaints / Return & Retain Examination Support
Company: Intellectt Inc.
Location: Rensselaer, NY
Employment Type: W2 Contract
Pay Rate: $42/hr on W2
Work Arrangement: Onsite

Job Description:
Intellectt Inc. is 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

• 5 7 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.

Recruiter Contact
Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

Benefits

Employees hired into this position are eligible for benefits subject to 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 the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is 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.