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QA Auditor II

Req ID #:  43031
Location: 

Charleston, SC, US, 29607

For nearly 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 e perform. In return, we’ll help you build a career that you can feel passionate about.

 

 

BASIC SUMMARY:  

Independently perform audits of a broad range of records and reports and inspections of a variety of 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 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. 
  • Host client site visits and participate in regulatory inspections.
  • Coordinate the development of corrective and preventative actions to respond to client visit and regulatory inspection findings. 
  • 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 all 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.
  • 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 with providing basic regulatory training to QA and operations personnel.
  • Assist in scheduling and tracking QA audits, inspections and procedures as requested.
  • Assist with review and revision of QA SOPs to reflect current practice.
  • Participate in collecting and reporting of quality metrics.
  • 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:   2-4 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:  Good working knowledge of Microsoft Office applications (e.g. Word, Access, Excel).  Good knowledge of applicable regulations and guidance documents; able to apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.

 

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.
  • 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 travel.

About Microbial Solutions
Our Microbial Solutions business group has a  comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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: Greenville
Nearest Secondary Market: South Carolina

Job Segment: Biotech, Pharmaceutical, Quality Assurance, Laboratory, Science, Research, Technology