QA Complaints Specialist

United Pharma Technologies Inc; New York (NY); On-site; USD 90,000 - 125,000; Full time

Job summary

United Pharma Technologies Inc is seeking an experienced QA Complaints Specialist to manage the full lifecycle of product quality complaints in a cGMP environment. You will coordinate investigations, review data across QA, Manufacturing, and Regulatory, and ensure timely closure with robust documentation.

The role requires 5+ years in pharmaceutical quality environments, strong analytical and cross-functional collaboration skills, and proficiency with common eQMS tools and regulatory

Qualifications

• Bachelor's degree in a scientific discipline relevant to pharma quality.
• 5+ years in Quality Assurance or product complaints in pharma/biopharma.
• Hands-on experience with complaint investigations and GMP/GDP quality systems.
• Understanding of deviations, investigations, CAPA, change control, and root-cause analysis.

Responsibilities

• Manage the full lifecycle of quality complaints from intake to closure.
• Review complaints for completeness and potential patient impact.
• Coordinate and conduct investigations, reviewing manufacturing and QA data.
• Assess regulatory reportability and escalation needs.
• Prepare clear investigation reports and maintain documentation within SOPs.
• Support CAPA activities and trend monitoring with quality metrics.

Skills

Quality assurance

Complaint investigations

cGMP/GMP

CAPA

Root cause analysis

Regulatory reporting

Documentation

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or related scientific discipline

Tools

TrackWise

Veeva Quality

MasterControl

Sparta

Job description

Industry: Pharmaceutical / Biopharmaceutical

Job Summary

We are seeking an experienced QA Complaints Specialist with 5+ years of experience in pharmaceutical or biopharmaceutical quality environments. The ideal candidate will have strong hands‑on experience managing product quality complaints, conducting and reviewing complaint investigations, evaluating regulatory reportability, and supporting CAPA and quality system activities within a cGMP‑regulated environment.

The individual will work closely with Quality Assurance, Manufacturing, QC, Regulatory Affairs, Pharmacovigilance, Customer Service, and other cross‑functional teams to ensure complaints are thoroughly investigated, appropriately documented, and closed within established timelines.

Key Responsibilities

• Manage product quality complaints throughout the complete complaint lifecycle, including intake, assessment, classification, investigation, evaluation, and closure.
• Review incoming complaints for completeness, accuracy, product information, and potential quality or patient‑safety impact.
• Conduct and/or coordinate investigations related to pharmaceutical product complaints.
• Review batch records, manufacturing records, laboratory data, stability information, distribution records, and other relevant quality documentation during investigations.
• Evaluate complaint information to determine potential regulatory reportability and escape reportable events to appropriate Quality, Regulatory Affairs, and Pharmacovigilance functions.
• Prepare clear, accurate, and technically sound complaint investigation reports and supporting documentation.
• Review investigation reports prepared by Manufacturing, QC, laboratories, Contract Manufacturing Organizations (CMOs), and other functional groups.
• Ensure complaint investigations are completed within established SOP, regulatory, and business timelines.
• Identify potential root causes and support investigations using appropriate root‑cause analysis methodologies such as 5 Whys, Fishbone/Ishikawa, and risk assessment tools.
• Identify recurring or systemic complaint issues and initiate or support CAPA activities when appropriate.
• Monitor complaint trends and prepare periodic metrics, dashboards, and reports to identify recurring product or process issues.
• Maintain accurate complaint records, databases, logs, and electronic quality system records.
• Ensure complaint documentation complies with GMP, GDP, data integrity, SOP, and internal quality‑system requirements.
• Partner with Manufacturing, QC, Engineering, Regulatory Affairs, Pharmacovigilance, Supply Chain, and Customer Service to obtain information required for investigations.
• Coordinate with external manufacturers, laboratories, vendors, distributors, healthcare professionals, and other stakeholders as required.
• Support product quality risk assessments and escalation of potentially significant quality issues.
• Participate in deviations, nonconformances, change controls, CAPA, and other quality‑system activities associated with complaint investigations.
• Support internal and external audits and regulatory inspections by providing complaint records and investigation documentation.
• Identify gaps in complaint processes and contribute to continuous improvement initiatives.
• Support development and revision of SOPs, work instructions, forms, and complaint‑management procedures.
• Ensure complaint records are inspection‑ready and appropriately maintained throughout the record‑retention period.

Required Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or related scientific discipline.
• 5+ years of experience in Quality Assurance, Product Complaints, Quality Systems, Manufacturing Quality, or a related function within the pharmaceutical or biopharmaceutical industry.
• Strong experience with pharmaceutical product complaint investigations.
• Hands‑on knowledge of cGMP/GMP requirements and pharmaceutical quality systems.
• Experience with deviations, investigations, CAPA, change control, and root‑cause analysis.
• Knowledge of FDA requirements and applicable pharmaceutical regulations, including 21 CFR Parts 210 and 211.
• Experience evaluating complaints for regulatory reportability and appropriate escalation.
• Strong technical writing and investigation‑report writing skills.
• Strong analytical, problem‑solving, and organizational skills.
• Ability to manage multiple complaints and investigations while meeting established timelines.
• Strong communication and cross‑functional collaboration skills.
• Proficiency with Microsoft Excel, Word, and PowerPoint.

Preferred Qualifications

• Experience with TrackWise, Veeva Quality, MasterControl, Sparta, or other eQMS/complaint‑management systems.
• Experience working with pharmaceutical manufacturing, sterile/aseptic products, oral solid dosage, biologics, or combination products.
• Knowledge of ICH guidelines, FDA guidance, GDP, data integrity, and risk‑management principles.
• Experience working with Contract Manufacturing Organizations (CMOs).
• Experience with complaint trending, KPI reporting, and quality metrics.
• Experience supporting FDA or other regulatory inspections.
• Familiarity with Pharmacovigilance / adverse event processes and coordination between Quality Complaints and Drug Safety.