Job Description
Job Overview
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). Responsible for supporting preliminary reviews of local quality requirements from the Quality Management System (QMS). Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management.
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.
• 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.
• Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
• Participate in the process the execution of improvements that have been agreed upon with Operations and Quality Management.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections; assure QA audit files are retained.
• Participate in the preparation of support during regulatory inspections, as required.
• Communicate all identified compliance and quality risks to senior team members and quality 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 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.
• 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 6 months in a Quality Assurance or regulated industry role.
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.
The pay for this position is $22.50 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.