QA Product Complaint Manager

LNK International•Hauppauge, NY

About The Position

LNK International, a pharmaceutical manufacturer in Hauppauge, Long Island, New York, is seeking an experienced QA Product Complaint Manager for its Quality department. The position reports to the Director, Quality Assurance and manages compliant handling of product complaints associated with commercial OTC products. The role oversees complaint intake, assessment, investigation, documentation, and closure in accordance with applicable regulations and company procedures, working with Manufacturing, Packaging, the QC Laboratory, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance. The manager oversees the complaint process and complaint-system database and files; reviews complaint records, investigations, assessments, consumer communications, and closure documentation; coordinates investigations, follow-up, sample returns, and laboratory testing; and handles complaint responses and consumer adverse-event reporting in accordance with SOPs. The role also supports quality-system implementation and monitoring, SOP adequacy and creation or approval, trend identification and corrective action, ANDA complaint documentation for periodic submissions, audits, and departmental statistics. Other duties within the Quality organization may be assigned.

Requirements

Bachelor's degree in a related field or equivalent years of work experience.
At least 4 years of relevant experience in the biotech or pharmaceutical industry.
At least 3 years of experience managing pharmaceutical product complaint processes.
Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities.
Working knowledge of cGMP requirements and quality management systems.
Strong knowledge of FDA, global GMP, pharmacovigilance, and product complaint regulations and guidance.
Excellent written and verbal communication skills, including the ability to communicate effectively across all levels of the organization.
Computer experience and broad knowledge of Microsoft Office, including Word and Excel.
Highly organized and detail-oriented.

Responsibilities

Manage intake, assessment, documentation, investigation, and closure of commercial product complaints in accordance with applicable regulations and company procedures.
Receive, evaluate, and process complaints, identifying and forwarding potential adverse events, lack-of-effect reports, and product quality reports to appropriate functions.
Conduct and coordinate complaint investigations with internal and external stakeholders.
Ensure complaint records are complete, accurate, fact-based, well-written, and inspection-ready.
Manage follow-up with consumers, healthcare professionals, pharmacies, distributors, and other external contacts to obtain complaint information and supporting documentation.
Coordinate product sample returns, sample tracking, laboratory testing requests, and related documentation.
Draft and issue complaint response communications as required and ensure complaints are communicated to consumers accordingly.
Review and approve complaint records, investigations, assessments, customer communications, and closure documentation for completeness, accuracy, compliance, and adherence to company procedures.
Exercise independent judgment to evaluate complaint information, determine investigation requirements, assess product quality impact, and recommend disposition and closure activities.
Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.
Ensure company SOPs are adequate and meet GMP standards, including approving and creating SOPs as appropriate.
Identify complaint trends and inform appropriate personnel for corrective action.
Assist the Director of Quality with implementation and monitoring of the quality system.
Manage complaint investigations and adverse-event reporting for consumer complaints in accordance with SOPs.
Oversee the complaint system database and complaint files.
Ensure ANDA complaint documentation is collected and provided for periodic submissions.
Participate in internal, external, and regulatory audits.
Provide statistics relevant to the department.
Perform or oversee other duties within the Quality organization as required.