Senior Quality Systems Specialist

Company: Lantheus Holdings, Inc.
Location: Billerica
Posted on: June 12, 2021

Job Description:

Summary

Responsible for managing the Product Quality Complaints process, including associated investigations, remediation actions, adverse events, field alert escalations, recalls and related metrics reporting. Other functional responsibilities include authoring and revising Quality System Documentation, analysis of quality data to drive continuous improvement of the Quality Management System (QMS) processes.

Key Responsibilities/Essential Functions

• Manages Product Quality Complaints collaborating with external and internal stakeholders; including; processing incoming complaints, tracking them through QMS, coordinating sample returns, ensuring timely Complaint investigations and closure, and to preparing periodic Complaint reports.
• Collaborates with internal groups (e.g., Technical Support, Engineering, QC Laboratories, Manufacturing, etc.) to ensure timely Complaint investigations, and drives closure of associated remediation actions.
• Analyzes Product Quality Complaints and performs routine trending and evaluation of trends, escalates issues in a timely manner as necessary.
• Coordinates records management for the Quality Compliance Team, including folder organization and ensuring compliance with the records retention policy.

• Creates weekly and monthly Complaints metrics, including PPM analysis, reconciliation to GPV agency records and metrics for Quality Council

• Participates in internal and external audits, reviews documents for compliance with regulatory guidelines and applicable Standard Operating Procedures (SOPs).
• Works with cross functional teams to initiate and drive continuous improvement initiatives of the quality system processes, manage change controls and implementation.
• Actively demonstrates the Lantheus values of Accountability, Quality, Customer Service, Efficiency, Collaboration and Safety.
• Performs other duties, as assigned.

Basic Qualifications

• BS/BA degree in a related medical, science or engineering discipline or equivalent training and formal experience; minimum 5 years' experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries.
• Strong Knowledge of quality systems, including Product Quality Complaints, CAPA, Document Management and Auditing
• Working knowledge of pharmaceutical regulations ((including FDA, Health Canada and other international regulations)
• Excellent verbal and written communication and collaboration with various internal and external business partners in problem resolution. Ability to create, revise and review company documentation.
• Advanced computer skills, data reporting and quality analyst capabilities are a plus (Excel / AssurX CatsWeb / Visual Basic / SQL).
• Experience with conducting audits or as a Certified Auditor a plus.

Keywords: Lantheus Holdings, Inc., Billerica , Senior Quality Systems Specialist, Other , Billerica, Massachusetts