Quality Compliance Associate – Complaints / Return & Retain Examination Support

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:

• 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.

Key Skills: GMP compliance, pharmaceutical quality assurance, product complaint handling, complaint documentation and reconciliation, deviation reporting, drug product shipment QA oversight, batch disposition and sampling data review, LIMS, eQMS, CMO/vendor coordination, and pharmaceutical regulatory compliance.