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Senior Quality Assurance Auditor

Senior Quality Assurance Auditor
Req ID #: 38155
Location:
Ashland, OH, US, 44805
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
We are seeking a Senior Quality Assurance Auditor, for our Safety Assessment Group located in Ashland, Ohio.
The position is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.
BASIC SUMMARY:
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.
About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 70% of the drugs approved by the FDA in 2016.
For more information, please visit www.criver.com.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
Nearest Major Market: Cleveland
Nearest Secondary Market: Mansfield
Job Segment: Biotech, Pharmaceutical, Quality Assurance, Biology, Laboratory, Science, Technology



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