Independently perform audits of scientifically intricate records and reports and inspections of novel or complex processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.
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 supervisor.
•Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
•Review/approve SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
•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.
•Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained. May host client site visits and manage regulatory inspections.
•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.
•Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles.
•Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
•Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
•Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
•May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
•Assure the suitability of materials and supplies for compliance with specifications.
•Assist in developing and providing basic and advanced regulatory training to QA and operations personnel.
•Assist in scheduling and tracking QA audits, inspections and procedures as requested.
•In GMP facilities, review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product.
•Assist with review and revision of QA SOPs to reflect current practice.
•Participate in collecting and reporting of quality metrics.
•Serve as the lead in completing Regulatory Affairs and Compliance projects.
•Perform all other related duties as assigned.Qualifications
- Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- Experience: 3-5 years experience in a QA role.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet