Quality Systems Specialist II

Job Summary

Responsible for assisting/performing facility, process, vendor, and local validation activities to assure compliance with applicable federal, state and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP). Understand the voice of the customer and make recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management. Approximately 10% of this role's responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone)

Responsibilities : 

• Assure Company's compliance with applicable federal, state and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor
• Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations
• Provide recommendations to Operations and Quality Management for improvements in auditing of quality systems based on knowledge and understanding of current regulatory inspection guidance and internal trends
• Assist in tracking of QA audits, inspections and procedures, as applicable
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May host client site visit
• Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings
• Support the execution of corporate compliance assessments/mock-agency inspections of other sites
• Coordinate and facilitate site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members
• Participate in the preparation of support during regulatory inspections as required
• Independently perform internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management
• Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies
• Perform facility and equipment records and logbook reviews
• Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations
• Support meeting the review requirements for Customer or Supplier related Quality Agreements
• Support or conduct process based inspections as deemed necessary
• Assist in identification of any regulatory risk areas
• Assist with reporting, analysis and collection of site Quality Metrics via QMS
• Assist with preparations for Quality Management Review (QMR) and support during the QMR
• Provide process-improvement recommendations for dashboard analysis and analyze metric data for QMS
• Participate in coordination of Quality Assurance projects
• Assist with providing basic regulatory training to QA and operations personnel
• Provide timely responses to Customer inquiries to support their qualification/regulatory requests 
• Perform all other related duties as assigned

Job Qualifications

• Education : Bachelor's degree (B.S. / B.A.)or equivalent in a life science 
• Experience : Minimum of 5 years in a Quality Assurance role
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Other : Some experience with Microsoft Office applications. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential