Quality Systems Specialist

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 participate in identifying recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management. Approximately 5% of this role's responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone).

ESSENITAL 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 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.

· 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.

· Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.

· Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.

· Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.

· Participate in the execution of 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.

· Participate in the performance 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.

· Perform facility and equipment records and logbook reviews.

· Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.

· Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members.

· Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.

· Assist with analysis and collection of site Quality Metrics via QMS.

· Assist with preparations for Quality Management Review (QMR).

· Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS.

· Participate in execution of Quality Assurance projects.

· Assist with providing basic regulatory training to operations personnel.

· Provide timely responses to Customer inquiries to support their qualification / regulatory requests.

· Perform all other related duties as assigned.

QUALIFICATIONS:

· Education: Bachelor's degree (B.S. / BA.A.) or equivalent, preferably in a life science.

· Experience: Minimum of 2 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.

PHYSICAL DEMANDS:

· Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.

· Must regularly communicate with employees/customers; must be able to exchange accurate information.

· Must occasionally move about inside the office to access file cabinets, office machinery, etc.

· May occasionally be required to wear protective clothing and equipment.

WORK ENVIRONMENT:

· General office working conditions and/or laboratory/manufacturing areas.

· The noise level in the work environment ranges from low to moderate.

· May occasionally be required to work in tight or confined spaces.

· May occasionally be exposed to high temperatures and humidity.

COMMENTS:

· May require occasional domestic and/or international travel (up to 10%).