Sr. Quality Assurance Auditor - GMP

Sr. Quality Assurance Auditor - GMP Req ID #:  161713 Location: 

Durham, NC, US, 27703 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly. Job 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. Job Qualifications QUALIFICATIONS:

•    Education: Bachelor's degree (B.A./8.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.

•    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.

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 travel.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. 

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 18,000 employees within 100 facilities in over 20 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. 

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 >80% of the drugs approved by the FDA for the past 3 years.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh

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