Edison-New Brunswick Metro Area, NJ
- Quality Complaints Specialist - Responsible for Product Quality Complaint initiation and oversight for the Product Quality Complaints Global Operations department, focusing on daily management of complaints.
- Requirements - Minimum of 5 years relevant work experience.
College or university degree preferred. Equivalent combination of education and experience acceptable.
- Provide daily support to the system business process owner for the eQRMS electronic Product Quality Complaint module including all file related transactional activities.
- Global responsibility, requiring cross-functional collaboration that has an impact on departmental performance through contributions to key Quality initiatives. Additionally, this role will provide broad support to the Global Quality Systems team as needed with a core focus on eQRMS and QUADs platforms.
- Must have broad GMP and Quality knowledge.
- Must be able to prepare written communications and communicate problems to management with clarity and accuracy.
- Must have broad technical and scientific knowledge. Must understand fundamental scientific problems.
- Must be able to write and review reports with clarity and brevity. Must be able to produce data reports with precision
- Must be able to provide guidance to other employees in technical writing skills.
- Experience with the development and deployment of Quality System technology solutions and platforms including user acceptance testing.
Responsible for entering Customer Complaint information into complaint database (eQRMS) per Departmental SOPs.
o Inputs all received product quality complaints into the electronic complaint system.
o Reviews received documentation and works with the Initiator group for follow-up activities.
o Performs Complaint classification and severity assignment
o Performs Unit trending for Complaint
o Facilitates sample return with Designated POC/ Logistics for return product assessments
o Issues Management Notifications for Critical complaints
o Assigns Complaints to the Site Quality Operations/ VQM for investigation
o Generates and distributes response letters, as applicable.
Provides oversight for PQC Process
o Performs weekly reconciliations with Drug Safety/ Affiliates
o Forwards weekly list of closed complaints to the appropriate Drug Safety departments
o Provides a monthly reconciliation lists to Customer Care/order Processing/Medical Information
Global SOPs, Work Practices, Job Aids
o Responsible for providing Training as SME on Complaint Process
o Responsible for maintaining and updating Complaint SOPs, Work Practices, Job Aids and Training Materials
eQRMS complaint database
o Supports enhancements and upgrades to complaint system and user acceptance Testing
o Manages User community feedback to implement process Improvements to eQRMS
o Supports ad hoc requests from customers
Provides PQC data to support Metrics, APRs, and Quality review forums, as needed.
o Supports Senior Management Review meetings with PQC data
o Supports Monthly Metrics Report generation
Provide broad support to GQS Systems and Business Process Owners
o Provides directed support to all GMP eQRMS Modules including CAPA, Deviation and GCM