Product Complaint Specialist

Company: Alpha Consulting
Location: New Brunswick
Posted on: May 24, 2023

Job Description:

PRODUCT COMPLAINT SPECIALIST NEW BRUNSWICK, NJHybrid Role. Must be an enrolled student.Required Skills:

• BS/BA in Sciences (i.e. Chemistry, Biology, Biochemistry, Microbiology, Pharmacy), engineering, business.
• Enrolled in Bachelor's, master's, or MBA degree program.
• Preferred Completion of bachelor's and enrolled in graduate studies.
• Microsoft Office (Power point, Excel, Word, Outlook).
• Project Management expertise with advanced PowerPoint preferred.
• Basic statistics/analytics; clear communications.
• Ability to manage deliverables within target timelines.
• Must have strong analytical, interpersonal, communication, organization, and project management skills and passion to learn and grow within the biopharmaceutical industry. Project Description:
  • Support the Global Product Quality Complaint (PQC) process for the biosterile, pharmaceuticals and combination drug/device products with respect to product quality complaints.
  • Analyze, identify and execute continuous improvement initiatives within the process while collaborating within the PQC headquarters team as well as with key stakeholders, including internal and external sites and in-market supply chain quality.
  • This individual will be a valued team member of one of several cross-functional, multi-divisional teams which are responsible for developing and executing Global Quality Systems (GQS) initiatives and strategies for BMS, with focus on the global PQC process.
  • Provide ongoing management for PQCs ensuring compliance to global framework of GMP policies and BMS procedures.
  • Support the Global Product Quality Complaint (PQC) processing activities at PQC Headquarters.
  • Participate in PQC HQ team meetings for the processing of, and improvements to, global BMS PQC processes, including but not limited to: PQC case intake, triage, due diligence activities, product replacements and patient reimbursements/refunds; metrics generation and slide presentation; PQC training delivery and management; new product launches; PQC related Quality Management System (QMS).
  • Support tracking, trending and other ancillary activities for controlled documents (SOPs/Job Aids/Templates); record archivals; quality deviations and CAPA involving PQC HQ and provide quality and compliance support for these processes.
  • Assist in implementation of Quality Risk Management principles in evaluation and investigation of PQCs.
  • Support PQC related audits and inspections, as necessary.
  • Participate in QMS business process requirements development and validation activities as necessary.
  • This opportunity is cross functional and will involve the management of mid-size projects between PQC HQ and other areas of the organization. This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: ALPHA'S REQUIREMENT #23-00811MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting, New Brunswick , Product Complaint Specialist, Other , New Brunswick, New Jersey