USA - Senior Quality Compliance Specialist

True Title: Biologics & Plasma Complaint Lead

6 Month Initial Contract

Lexington, MA (Onsite)

Summary

Quality Compliance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint administration, investigation and reporting, Product Quality Review / Annual Product Review (APQR), Product Recall, Incident Management, and support for the integration of new product acquisitions into post marketing surveillance.

Job Responsibilities

• Post Marketing Product Quality Surveillance:
• Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
• Effective global Product Annual / Periodic Product Quality Review
• Preparation as per applicable SOP
• Supports Global System for Product Quality Reviews/Annual Product Review
• Coordinate APQR Review meetings
• Create and Track APQR elements. Follow-up on pending items and facilitate discussions to resolve outstanding items
• Responsible for maintaining a schedule for APR/PQR; responsible for obtaining and compiling required data from various internal and external suppliers, manufacturers and packagers of our Product.
• Review SOP periodically for compliance.
• Provide QA input on compliance issues concerning Product Quality Reviews.
• Acquisition & Integration & Project Support:
• Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including but not limited to; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring
• Support and participate in Quality and cross-functional project teams. Regulatory Awareness, Inspection support and Compliance
• Maintain awareness of MHRA/EMA/FDA/DEA, etc. regulatory actions that may affect company products.
• Supports regulatory reporting and submissions as applicable.
• Keep informed of all regulatory changes, rulings and current industry practices concerning Post Marketing Surveillance activities.
• When appropriate, assist in regulatory inspections regarding client products and post marketing product surveillance activities
• When appropriate, assist in regulatory notification or market correction activities (i.e. field alert / recall activities)
• Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including but not limited to CAPA, Deviation, etc)

Education & Qualifications

• Preferred Experience with TrackWise and APQR preferred.
• MS or Bachelors degree in a relevant scientific/engineering discipline with at least 3 years GMP industry experience, the majority of which has been gained in the Quality environment and includes manufacturing