Manager / Lead Associate, Quality-Complaints

Purpose:

The Manager / Lead Associate will play a pivotal role in maintaining and enhancing the quality complaints system. This individual will be responsible for handling and processing complaints to ensure that our products meet regulatory requirements and exceed customer expectations.

Responsibilities:

• Analyzing the final investigation received from the respective manufacturing and packaging units to ensure accuracy and completeness.
• To assist in appropriately handling the initial receipt of technical complaints and triaging the respective partner.
• Handle & Process complaint samples efficiently and accurately.
• Assess the CAPA effectiveness and provide recommendations for the manufacturing and packaging sites to ensure that all corrective and preventive actions are effectively preventing the recurrence of identified issues.
• Identification of critical complaints that have the potential to cause field alerts or recalls.
• Creation of metric reporting to track complaint volume, trends and critical issues in order to update management on the market complaint issues.
• Monitor and assist with assigning complaints, updating the complaints database, tracking complaint investigation status, assisting in the completion of failure investigations, obtaining signatures, generation of responses to customers.
• Oversee the effective and timely review of incoming product complaints and Investigations to ensure that all pertinent technical observations are accurately captured with respect to the product complaint reporting processes.
• Suggest strategies to improve complaint processing cycle time, customer complaint processing, investigations and/or customer response processes.
• Interfaces with the Pharmacovigilance personnel and MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE.
• Interfaces with MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE.
• Ongoing support of complaint system (changes to processes, and qualification where applicable).

Qualifications / Skills:

• B.S. or M.S. in life sciences is preferred; chemistry, biology, or Pharmacy etc.
• A minimum of 5 years’ experience in a GMP setting of the pharmaceutical or medical device industry
• Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents.

Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Equal Opportunity Employer:

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.