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Product Quality Complaint Analyst

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: March 28, 2020

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.We are seeking a qualified and motivated team player to support the Global Product Quality Complaint (PQC) operations at New Brunswick, NJ. The primary responsibility for this position includes review and triage of incoming product quality complaints, facilitate communications for individual complaint records as necessary between PQC Head Quarter function, Medical Information Contact Centers and Site and Local Market teams. Identify any compliance gaps and inefficiencies and provide input in implementation of solutions. Generate Product Quality Complaint Metrics per established procedures. Support the management of the global complaint handling process from receipt to closure ensuring quality & compliance with internal and regulatory requirements. Assist in establishment of Quality Risk Management principles in evaluation and investigation of PQCs.Position Responsibilities:This role will execute routine day-to-day tasks Product Quality Complaint transactional tasks within established timeframes including but not limited to:Input of PQCs into an electronic complaint system as required. Ensure accurate and timely triage of incoming PQCs that may include assessing the reported information for completeness, determine the appropriate complaint category and severity, assignment to the investigating site, local markets and site PQC process owners. Resolve day-to-day triage assignment inaccuracies and issues. Ensure that complaints which require expedited review are identified and escalated to appropriate local markets, sites and senior management promptly per established procedures. Perform Unit trending, as needed. As appropriate, facilitate the collection of additional complaint information relevant for the investigation. Assist in the product return, replacement and reimbursement processes for complaint investigation samples. Contributes in the development of departmental procedures that support the PQC system ensuring all documents and processes comply with applicable regulations, guidance documents and industry best practices. Perform review and closure of PQCs upon completion of investigations including generation and distribution of customer response letters per established procedure and timeframes. Collaborate with cross-functional system internal and external partnersUpon request by PQC HQ Management, perform the following support activities:Periodic product quality complaint metricsGeneration of ad hoc reportsReconciliation of complaints received and transferred between organizations (e.g., Pharmacovigilance, Medical Information) to ensure all are documented as required in the Quality Management System for accountability of all PQC cases globally.Provide support during internal/external audits and inspectionsProvide backup coverage for the other day-to-day activities of the PQC HQ department, such as management of PQC general mailbox, SharePoint sites, archival of documents, etc.Provide support to Product Surety and Serialization management as requested.Perform other duties as assigned by PQC HQ management.Competencies - Knowledge, Skills, Abilities:

  • GMP and Quality knowledge, particularly in the area of Product Quality Complaint handling.
  • Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms used to execute quality processes
  • Must be able to evaluate data and produce reports with precision.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with no supervision; work is self-directed; confident in making non-routine decisions in their subject matter area.
  • Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio (Expert knowledge in the utilization of Excel is preferred).
  • Critical thinking to understand and operate under complex global environment.
  • Demonstrated experience working with complex processes, detailed, organized, and ability to multi-task, balance conflicting priorities
  • Excellent verbal and written communication in English
  • Ability to work cross-functionally within the organization with all levels of leadership
  • Ability to build strong relationships by being transparent, reliable and delivering on commitmentsExperience - Responsibility and minimum number of years:
    • A minimum of 3 years of pharmaceutical industry experience with at least 2 years in handling of Product Quality Complaints. Will consider an advanced degree in lieu of years of experience.
    • Global experience working in mid to large biopharmaceutical with prescription drug dosage forms and combination productsQualifications:Degree/Certification/LicensureMinimum of a Bachelor's Degree required in Sciences, Pharmacy, Nursing, Chemical Engineering or Bio-Medical Engineering or related fields.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.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Product Quality Complaint Analyst, Professions , New Brunswick, New Jersey

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