Senior QA Product Complaints Lead

LNK International Inc.; Hauppauge (NY); Presencial; USD 85.000 - 112.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

401(k)

Descripción de la vacante

LNK International Inc. in Hauppauge, NY, seeks an experienced Quality Assurance Product Complaint Manager to join our fast-paced team.

The role handles intake, investigation, documentation, and closure of product complaints for commercial OTC products, ensuring compliance with regulatory requirements and company procedures. The successful candidate will possess a Bachelor's degree in a related field, 4+ years of biotech/pharma experience, and strong FDA/GMP knowledge along with excellent

Formación

• Bachelor's degree in a related field required.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities required.
• Working knowledge of cGMP requirements and quality management systems required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry, bachelor's degree or equivalent years of work experience.
• Minimum 3 years of experience managing pharmaceutical product complaint processes.
• Strong knowledge of FDA, global GMP, pharmacovigilance, and product complaint regulations and guidance.
• Strong written and verbal communication skills, across all levels of the organization.

Responsabilidades

• Manage intake, assessment, documentation, investigation, and closure of product complaints for commercial products.
• Coordinate complaint investigations with internal and external stakeholders to obtain necessary information.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Oversee complaint system database and files; support regulatory submissions as needed.
• Assist in implementing and monitoring the quality system; trend notes for CAPAs.

Conocimientos

Quality Assurance

cGMP knowledge

Regulatory compliance

Investigation skills

Documentation

Verbal & written communication

Organizational skills

Educación

Bachelor's degree in a related field

Herramientas

Microsoft Word

Microsoft Excel

Descripción del empleo

LNK International Inc. in Hauppauge, NY, seeks an experienced Quality Assurance Product Complaint Manager to join our fast-paced team.

The role handles intake, investigation, documentation, and closure of product complaints for commercial OTC products, ensuring compliance with regulatory requirements and company procedures. The successful candidate will possess a Bachelor's degree in a related field, 4+ years of biotech/pharma experience, and strong FDA/GMP knowledge along with excellent