Company:  Confidential

Job Title: Complaint Specialist

Job Number: 34540

Location: 12390 El Camino Real San Diego, CA 92130

Job Description

Responsibilities

  • Conducting complaint investigations and associated tasks to ensure complaint investigations are thorough, investigation conclusions are appropriate, appropriate procedures are followed, and complaint investigations are conducted and closed in a timely manner. 
  • Reviewing & identifying the root causes of complaints and works with the applicable operational departments such as: Product Development, Manufacturing Engineering, and Quality Engineering to ensure an appropriate resolution.
  • Responding directly to customers to investigate and resolve complaints, when necessary. 
  • Assisting in the development of training materials and process enhancements related to complaints management.
  • Facilitating complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation, as needed.
  • Participate in quality management system meetings regarding complaints and complaint handling.
  • Performing duties in accordance with the Company’s Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
  • Providing input to support the continual improvement of complaint handling processes.
  • Performing other related duties as assigned.

Required Skills

  • Strong computer skills.  Proficiency with Microsoft Office business software and use of information databases
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Proven ability to communicate effectively; orally and written
  • Ability to manage multiple tasks and projects
  • Able to work independently, as well as in a cross-functional team environment
  • Customer service oriented attitude and ability to exercise sound business judgment
  • Ability to maintain confidentiality and discretion in business relationships
  • Able to define problems, organize and collect data, establish facts, and draw valid conclusions
  • Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
  • Travel between sites as needed

 

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