For 75 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.

Job Summary

Duties & Responsibilities

Responsible for timely archiving or records, checking for good documentation practices and data integrity.
Participate in the preparation of records and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.
Supports change management processes including monitoring of activities, action verification and its due date and working closely with other departments to ensure timely completion of actions.
Supports the quality system operations such as monitoring of investigation due dates, CAPAs, Internal audit completion, test protocol approvals and working with other department to ensure timely closure or extension.
Review quality records such as logbooks and manage its issuance.
Approve customer test reports and participate in reagent, equipment and facility release activities to support laboratory operations.
Assist in monitoring and verifying training and document management activities.
Performs all functions as tasked with high degree of accuracy and strict adherence to company's quality requirements.
Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, Company global SOPs and data integrity principles for all activities.
Assists in quality system projects that involved system implementation for cGMP compliance

Requirements

Education: Life Science Diploma, Bachelor's degree or equivalent
Other: Some experience with Microsoft Office® applications. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential.
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.

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 20,000 employees within 110 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 in the last five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

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, or national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [HIDDEN TEXT]. 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.

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QA Specialist (Contract)