Bristol Myers Squibb Product Quality Complaints Analyst in New Brunswick, New Jersey
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 and
investigation of product complaints received on site.
• Process, investigate and data entry of complaints into Trackwise database.
• Identify and report on complaint trends; define and track 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
• Support 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:
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. Manage and/or perform investigations for lack of effect complaints, including reconciliation process with Global Pharmacovigilance. Provide follow-up for complaints which require expedited review and are escalated to the manufacturing sites and Quality management;
Communicate investigation outcomes.
Analyze PQC data in order to identify and report complaint trends
Define and track performance metrics to assure compliance processing complaints.
Interface with manufacturing sites, complaint managers, Device Quality, Device Operations, and Global Pharmacovigilance.
Provide support for the day-to-day activities of the product quality complaint management team.
Provide support for implementation of risk-based investigation strategies for complaints against drug-device combination products and other applicable products
Perform other duties as assigned.
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:
Proven organization management skills to process large volumes of complaints in the BMS PQC database in a fast-paced environment.
Must be able to work independently as well as in a team setting.
Laboratory experience with complaint investigations and visual inspections.
Attention to detail and entering accurate information is required.
Proven excellent writing skills to capture investigations clearly and accurately.
Proven excellent communication skills to interface with our customers/stakeholders.
Ability to recognize issues and escalate to senior management as necessary.
MS Office experience required.
Experience in TrackWise preferred.
Previous experience in creative problem solving and critical thinking skills; experience in “continuous process improvement” is preferred.
Experience with medical devices preferred.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.