Product Complaint Specialist Temp

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Location

Ardsley, NY

Summary

The Product Quality Complaint Specialist is responsible for Product Quality Complaint handling. This includes Complaint receipt into the Product Complaint system, categorization, coding, processing and investigation, reporting and closure of the complaint, to ensure Compliance to the FDA and other worldwide health authority CGMP Regulations and guidelines, Acorda Standard Operating Procedures and industry standards.

Full Description

The Product Quality Complaint Specialist is responsible for Product Quality Complaint handling. This includes Complaint receipt into the Product Complaint system, categorization, coding, processing and investigation, reporting and closure of the complaint, to ensure Compliance to the FDA and other worldwide health authority CGMP Regulations and guidelines, Acorda Standard Operating Procedures and industry standards. 

Essential Duties and Responsibilities including the following. Other duties may be assigned

  • Monitor the Complaint mailbox to assure that items received in the mailbox are processed in a timely manner. Assure that complaints are triaged as to the specific product involved, severity of the complaint and the specific related criteria or the perceived physical defects in the product or the combination product.
  • Gather and verify the complaint information; Accurately document, research and resolve as per applicable
  • Assure that the related log entries are complete and monitored for completion and accuracy of content.
  • Issue Complaint reports
  • Ensure the complaint investigations are handled, completed and closed in the timelines specified
  • Communicate and collaborate with internal and external stakeholders as applicable
  • Participate as requested in the Complainant interview process
  • Participate in the investigations for products controlled by CMO’s contracted by Acorda Ardsley; Perform root cause analysis
  • At the direction of complaint management, respond to complainants regarding the outcome of the complaint investigation
  • Participate in metrics tracking and trends as well as well as compliance issues and their resolution; analyze monthly data to identify new and systemic issues

Education and / or experience

  • Bachelor’s Degree in Life Sciences  
  • Minimum of five (5) years of experience in the pharmaceutical industry with a minimum of two (2) years in Quality Assurance GMP Complaint Handling
  • Experience with medical device or Combination Products is a plus

Supervisor Responsibilities:  None

Qualifications:

  • Strong knowledge of CGMP concepts
  • Knowledge and understanding of FDA and ICH CGMP requirements regarding product complaints, field alerts and medical device reporting requirements

Computer Skills:

  • Must be proficient in MS Office Suite.

Certificates, Licenses, Registrations:

  • None 

Other Skills and Abilities:

  • Must be well organized and demonstrate a keen attention to detail and timelines.
  • Excellent written, communication and presentation skills: Ability to write accurate and comprehensive reports
  • Ability to plan, schedule and prioritize routine work to meet established schedule and timelines
  • Must have Problem Solving skills
  • Ability to work in a fast paced environment
  • Ability to multi-task and adjust priorities as necessary
  • Must have a proven ability to work in a team environment
  • Ability to work both independently and in a collaborative team setting.
  • Ability to communicate across all levels of the organization.