Senior Quality Systems Specialist

Job Overview

BASIC 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). Independently responsible for conducting preliminary reviews of local quality requirements from the Quality Management System (QMS). While performing reviews of scientifically intricate records, reports, and inspections of novel or complex processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. Understand the voice of the customer and make recommendations to the Quality Management. Take a lead role in executing continuous improvement initiatives as supported by QMS metrics and/or site management. At a minimum, 20% of this role’s responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone).

Essential Duties and Responsibilities

•    Assure Charles River’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 management.
•    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 audits.
•    Provide recommendations to Operations and Quality Management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends.
•    Lead the preparation of study and QA files in preparation for client audits, sponsor site visits and regulatory inspections; assure that QA audit files are retained. May host client site visits and manage regulatory inspections. Along with the possibility of managing client inquiries, communications, and other audit related activities.
•    Develop recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. May coordinate the drafting of correspondence responding to client visits and regulatory inspections in conjunction with impacted departments. Report outcomes to upper management.
•    Review/approve SOPs, protocols/batch records, reports or other quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues or processes for accuracy and compliance with all applicable regulations and internal policies.
•    Participate in corporate compliance assessments/mock-agency inspections of other Charles River (CR) sites. To ensure records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.

Essential Duties and Responsibilites

•    Lead the execution of Coordinated Facility Audits on a variety of QMS topics that impact multiple CR sites.
•    Lead in updating training materials with applicable regulations or standards (ISO/GLP/GMP). Coordinating the performance and document site-wide training sessions.
•    Take a lead role in supporting regulatory inspections.
•    Perform qualification audits of subcontractors, as applicable.
•    Lead the execution and scheduling of 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.
•    Ensure the performance of facility, 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 and management of requirements for Customer or Supplier related Quality Agreements
•    Conduct process based inspections as deemed necessary.
•    Provide QA support in the validation of computer programs, controlled rooms, test methods, and manufacturing equipment.
•    Identify any regulatory/standard (as applicable) risk areas and provide recommendations for corrective actions to upper management.
•    Prepare and present the collection and reporting of site Quality Metrics via QMS.
•    Facilitate, host, and present at Quality Management Review
•    Provide recommendations for dashboard analysis and analyze metric data for QMS.
•    Participate and/or take a lead role in coordination of Quality Assurance projects.
•    Serve as a representative of Regulatory Compliance on harmonization teams.
•    Serve as project manager on assigned multi-site projects.
•    Provide training of Quality Assurance personnel with focus on QMS.
•    Perform all other related duties as assigned.

Qualifications

•    Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science.
•    Experience: Minimum of 8 years in a Quality Assurance role or regulated industry.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Other: Experience with Microsoft Office® applications and spreadsheet/database programs such as Access and Excel. 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.

The pay for this position is $34.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.