QA Product Complaint Manager

LNK International, Inc.•Town of Smithtown, NY

7d•$85,000 - $112,000•Onsite

About The Position

LNK International, a leading OTC pharmaceutical manufacturer located 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. It is responsible for complaint intake, assessment, investigation, documentation, and closure in accordance with applicable regulatory requirements and company procedures. The role collaborates with Manufacturing, Packaging, the QC Laboratory, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance. The manager oversees complaint processes and records, including potential adverse events and lack-of-effect reports, coordinates investigations and follow-up with internal and external stakeholders, and ensures documentation is complete, accurate, fact-based, and inspection-ready. The role also oversees complaint-system records, product sample returns and testing requests, complaint communications, trend reporting, and related quality-system activities. Additional duties include supporting the Director of Quality with quality-system implementation and monitoring, participating in audits, and providing departmental statistics. LNK offers competitive compensation and a full benefits package, including health and dental insurance and a 401(k).

Requirements

Bachelor's degree in a related field, or equivalent years of work experience.
At least 4 years of relevant experience in the biotechnology 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 proficiency, including broad knowledge of Microsoft Office, particularly 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, including identifying and forwarding potential adverse-event, lack-of-effect, and product-quality reports to appropriate functions.
Conduct and coordinate complaint investigations with internal and external stakeholders.
Ensure complaint records are complete, accurate, well-written, fact-based, 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.
Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.
Review and approve complaint records, investigations, assessments, customer communications, and closure documentation for completeness, accuracy, compliance, and adherence to company procedures.
Exercise independent judgment in evaluating complaint information, determining investigation requirements, assessing product-quality impact, and recommending disposition and closure activities.
Ensure company SOPs are adequate and meet GMP standards; this may include approving and creating SOPs.
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 according to SOP.
Oversee the complaint-system database and complaint files.
Ensure ANDA complaint documentation is collected and provided for periodic submissions.
Ensure complaints are completed and communicated to consumers accordingly.
Participate in internal, external, and regulatory audits.
Provide statistics relevant to the department.
Perform or oversee other duties within the quality organization as required.