QA Compliance Specialist II

Job Description

The Quality Assurance (QA) Compliance Specialist II will join the organization and its newly forming team in Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The site serves as the new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Lead aspects of quality and compliance to ensure compliance with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices), internal standards, and expectations for the development and reliable supply of quality medicines. Responsibilities include leading activities related to supplier qualification, change control, investigations and CAPA, complaints, Quality Risk Management, inspection readiness and metrics.

Essential Duties and Responsibilities :

• Working across functions, participate in the implementation and maintenance of the site’s quality system framework including quality systems and processes necessary to enable the development and reliable supply of the generic medications to patients.
• Implement, track, trend, and analyze quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Summarize findings and recommendations for management and team awareness and / or present at routine Quality Council meetings.
• Lead the assessment, qualification, and approval of suppliers.
• Participate in or lead internal self-assessment audits.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Working across functions to ensure compliant document control and training programs.
• Lead or participate in Quality Risk Management and Data Governance Processes as needed.
• Participate in activities to support regulatory agency inspections.
• Support site objectives with a minimal amount of supervision. Includes simple project management that may involve other functional areas.
• Promote a quality mindset and quality excellence approach to all activities.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
• Travel is limited but may occasionally be required.

Basic Qualifications and Capabilities :

Preferred Qualifications :