Associate Quality Systems Specialist

Charles River Laboratories; Newark (DE); On-site; USD 26,000 - 36,000; Full time

Benefits offered by this job

Bonus/incentives based on performance

401K

Paid time off

Stock purchase program

Health and wellness coverage

Employee and family wellbeing support

Work life balance flexibility

Job summary

Charles River Laboratories in Newark, DE is seeking a Quality Assurance support professional to assist with facility, process, vendor and local validations to ensure GMP compliance and adherence to SOPs. You will review regulated records and prepare audit materials while supporting QA metrics and regulatory inspections.

The role requires a Bachelor’s degree (life science preferred) and at least 6 months in QA or regulated industry; MS Office experience is expected.

Qualifications

• Bachelor’s degree (B.S. / BA / A.) or equivalent, preferably in a life science.
• Minimum of 6 months in a Quality Assurance or regulated industry role.
• Some experience with Microsoft Office® applications.
• Must communicate clearly, effectively and professionally; attention to detail and strong writing skills are essential.

Responsibilities

• Assist/perform facility, process, vendor and local validation activities to ensure GMP and SOP compliance.
• Review SOPs, protocols/batch records, reports and quality records for accuracy and compliance.
• Prepare audit records and countersign as trainee when applicable.
• Support QA metrics analysis and QMS reporting.
• Assist with QA files for sponsor site visits and regulatory inspections.
• Participate in quality improvement initiatives and dashboard analysis.

Skills

Communication

Attention to detail

Writing skills

Clear and professional communication

Education

Bachelor's degree (B.S./B.A.) or equivalent

Tools

Microsoft Office

Job description

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 Overview

Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP). Responsible for supporting preliminary reviews of local quality requirements from the Quality Management System (QMS). Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management.

Essenital 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.
• Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
• Participate in the process the execution of improvements that have been agreed upon with Operations and Quality Management.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections; assure QA audit files are retained.
• Participate in the preparation of support during regulatory inspections, as required.
• Communicate all identified compliance and quality risks to senior team members and quality management.
• Perform facility and equipment records and logbook reviews.
• Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
• Assist with analysis and collection of site Quality Metrics via QMS.
• Assist with preparations for Quality Management Review (QMR).
• Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS.
• Participate in execution of Quality Assurance projects.
• Perform all other related duties as assigned.

Qualifications

• Education: Bachelor’s degree (B.S. / BA.A.) or equivalent, preferably in a life science.
• Experience: Minimum of 6 months in a Quality Assurance or regulated industry role.

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.

The pay for this position is $22.50 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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
• 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 [e-mail]. 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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