Quality Assurance Lead - GMP

BioLegend has an immediate opening for a Quality Assurance Lead to oversee all applicable Quality Assurance processes for our US FDA registered cGMP manufacturing facility. This position will take the lead in ensuring the successful implementation of our MDSAP program. This is an opportunity with exciting career advancement opportunities that will spearhead the alignment of our existing quality system and applicable regulations with BioLegend’s Regulated product development activities.

This position will be responsible for supporting key quality elements such as document control, investigation management, validation, training, nonconformance, complaint management, and CAPA systems. The Quality Assurance lead will also be responsible for reviewing the quality records and final product releases per established quality management system.

Join us in enabling legendary discovery!

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Function as the primary Quality Assurance contact for our cGMP facility and participate in the quality audits for the diagnostics products
• Perform review of documentation of current and new products and procedures, including batch record release
• Participate and provide Quality Assurance guidance in product development gate reviews and reviews of design history files for new products
• Perform training activities for new hires, existing employees, and for procedural changes in compliance with Training procedure 
• Initiate, review, and implement the change control processes, including document changes (procedures, work instructions, forms, specifications and other related product documents) and process changes
• Ensure security, accuracy and compliance to Document Control requirements for all Quality Documents, including formatting, content changes, and processing
• Provide metrics data consisting of monthly reports, quarterly status of Quality Objectives, and other Quality Assurance data as needed
• Conduct internal quality audits with audit reports and follow up for timely closures
• Organize materials for presentations and participate in Management Review
• Review supplier qualifications and performance (purchasing and receiving)
• Support equipment qualifications and process validations as needed
• Manage the CAPA system with thorough records for root cause investigations and effectiveness checks
• Work closely with our Customer Service Department to address and track the customer complaints per applicable requirements
• Perform Quality Assurance inspections, including daily shipping inspection of new lots of finished goods products (as needed) to ensure bottling was performed correctly and that all documentation was completed as required
• Participate in the development of validation plans and reports for production processes and equipment

Competencies

• Accountability - Accepting responsibility that results in anticipation/prevention of problem areas from actions, and problem solving inside and outside the department/organization.
• Dependability - Amount of supervision required, punctuality and attendance.
• Quality of Work - Setting high standards regarding his/her work and working environment and acting accordingly; developing quality standards, continuously evaluating performance, products, and procedures; actively seeking ways to improve quality.
• Teamwork - Working as a productive member of a cohesive group toward a common goal, and contributing to team development and effective team dynamics.