Product Quality Complaints Analyst
Location:
Posted:
November 10, 2016
Reference:
1604719
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

This role is responsible for contributing to the proper management of customer complaint investigations. Other responsibilities include:

  • Assist with day-to-day activities and assignments of the investigation team, including physical receipt, triage an investigation of product complaints received on site.
  • Process, investigate and data entry of complaints into Trackwise database.
  • Identification and reporting on complaint trends; defining and tracking performance metrics
  • Develop, maintain and advance procedures to support business and compliance needs as they relate to Product Quality Complaint Management.
  • Escalation of product deficiencies that may require expedited review
  • Driving continual improvement projects to advance processes and capabilities
  • Supporting the Product Quality Complaint Management team as needed.

This is intended to be a general job description and should not be construed as all inclusive.

Major Duties and Responsibilities:

  1. Physical receipt, triage and investigation of complaints on combination drug products, including laboratory investigation for products received onsite, and document-based investigations when no product is returned.
  2. Provide follow-up for complaints which require expedited review and are escalated to the manufacturing sites and Quality management;
  3. Coordinate efforts with corporate security for cases regarding product surety.
  4. Communicate investigation outcomes..
  5. Analyze PQC data in order to identify and report complaint trends
  6. Define and track performance metrics to assure compliance processing complaints.
  7. Interface with manufacturing sites, complaint managers, and Device Operations.
  8. Provide support for the day-to-day activities of the product quality complaint management team.
  9. Perform other duties as assigned.


Qualifications:
Education:

This position requires 3-5 years experience in the pharmaceutical industry or healthcare-related field; product quality complaint investigation experience preferred. Bachelors Degree required.

Experience / Knowledge Desired:

  1. Proven organization management skills to process large volumes of complaints in the BMS PQC database in a fast-paced environment.
  2. Must be able to work independently as well as in a team setting.
  3. Laboratory experience with complaint investigations and visual inspections.
  4. Attention to detail and entering accurate information is required.
  5. Proven excellent writing skills to capture investigations clearly and accurately.
  6. Proven excellent communication skills to interface with our customers/stakeholders.
  7. Ability to recognize issues and escalate to senior management as necessary.
  8. MS Office experience required.
  9. Experience in TrackWise preferred but not required.
  10. Previous experience in creative problem solving and critical thinking skills; experience in "continuous process improvement" is preferred.
  11. Experience with medical devices preferred.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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