QA Specialist - Complaints

QA Specialist - Complaints

As a QA Specialist focusing on Complaints, you will lead investigations into Lack of Effect (LOE) and Product Quality Complaints (PQCs) for both internally manufactured and third-party produced or packaged products. Your role will involve collaborating with various teams to resolve product quality issues and ensure that all complaint-related information is accurately documented.

Responsibilities

• Lead investigations into Lack of Effect (LOE) and Product Quality Complaints (PQCs).
• Review investigation reports from internal departments and external partners, compiling comprehensive summary reports for complaint files.
• Collaborate with cross-functional teams, including Manufacturing, Packaging, Quality Control, and Corporate Quality Assurance, to address product quality issues and LOEs.
• Liaise with third-party manufacturers and packagers to facilitate complaint investigations for externally produced products.
• Coordinate with third-party call centers to gather additional complaint details as needed.
• Ensure accurate and complete documentation of all complaint-related information in official records.
• Consolidate findings and prepare summary reports in alignment with documentation standards and regulatory expectations.
• Adhere to Good Documentation Practices (GDP) during all stages of complaint handling and reporting.
• Manage receipt of complaint samples and oversee their dispatch to appropriate third-party laboratories for analysis.
• Follow established Standard Operating Procedures (SOPs) and Work Instructions throughout the complaint investigation process.
• Generate and maintain trend reports to monitor recurring issues and support continuous improvement initiatives.

Essential Skills

• Quality assurance
• Audit
• Complaints handling
• Batch record review
• Document control
• CAPA
• FDA regulations
• Inspection
• GMP
• Quality control

Additional Skills & Qualifications

• Minimum HS or AS degree
• 3+ years' experience in pharmaceutical complaint handling
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook
• Prior experience with TrackWise is a plus
• Strong command of English for frequent communication within the United States

Work Environment

Work as part of a team in the QA Complaints department. Enjoy benefits such as holiday pay and the opportunity for overtime based on manufacturing needs. The role is within an essential business that remains operational during shutdowns.

Job Type & Location

This is a Permanent position based out of Hauppauge, New York.

Pay and Benefits

The pay range for this position is $72000.00 - $93000.00/yr. Benefits start day 1 and they are eligible for 2 weeks vacation, 56 hours sick and wellness add 2 days mental health days.

Workplace Type

This is a fully onsite position in Hauppauge,NY.

Application Deadline

This position is anticipated to close on Oct 31, 2025.