Quality Assurance Auditor:
Charles River Laboratories

24921-en_US
Charles River Laboratories
Newark Delaware
Biotech
Description

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

 

 

BASIC SUMMARY:

Perform audits of protocols/batch records, raw data and final reports of medium complexity for routine and specialty assays, process documentation and labeling to assure accuracy and compliance with current Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP) and policies.  Perform reviews of incoming, in-process, and final product materials, with the authority for subsequent approval or rejection of these items against final product and material specifications.  Actively participate in hosting sponsor audits, and performing internal audits of Quality Systems.  Participate in collecting and reporting of site quality metrics and qualification audits of subcontractors.

 

ESSENITAL DUTIES AND RESPONSIBILITIES:

• Review SOPs, protocols/batch records and other controlled documents of medium complexity for compliance with all pertinent GMP regulations and internal policies.

• Review and approve or reject all incoming raw material receipt packages, and final products for compliance with the requirements detailed in final product and material specifications and applicable testing procedures.

• Review environmental monitoring data to ensure levels are in compliance with alert and action limits.

• Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with the GMP regulations, protocols and SOPs.

• Review and approve final reports to ensure accuracy and compliance with GMP regulations and the protocols; ensure that the final report accurately describes the raw data and test methods.

• Perform internal audits of Quality Systems (process/facility inspections/equipment and record review/computer validation activities/training records) to ensure compliance with current procedures.

• Determine and assure that exception documentation is appropriately reported and documented.

• Participate in the preparation for and hosting of Sponsor site visits.

• Participate in qualification audits of subcontractors as requested.

• Provide support during government/agency inspections as requested.

• Participate in Quality Assurance projects as requested.

• Perform all other related duties as assigned.

 

QUALIFICATIONS:

• Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science or related discipline.

• Experience: Minimum of 2 to 4 years in a Quality Assurance role.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Certifications/Licensure: N/A

• Other: Knowledge of Microsoft Office® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.

 

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is regularly required to talk, hear and work/type at a computer.

• Specific vision abilities required by this job include regular close vision and the ability to adjust focus.

• Must be able to regularly read, understand, and verify scientific text and data.

• On average, will sit 6 hours a day but on occasion could remain seated the entire day.  Conversely, there may be occasions where an auditor may have to be mobile throughout the work day.

 

WORK ENVIRONMENT:

• General office working conditions.

• The noise level in the work environment ranges from quiet to moderate.

•  May occasionally be required to wear protective clothing and equipment.

•  Employee frequently works with computers.

 

COMMENTS:

• This position does not require 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

Basic Qualifications
Requirement