Quality Systems Associate

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.

Quality Systems Specialist I will report to the manager in the Quality Systems organization, which manages oversite of GMP systems such as deviations, CAPA, Change control, and OOSs. You will support the site’s execution of and compliance to GMP, GDP, and FDA requirements by maintaining QMS data and overseeing the quality of regulatory documentation.

The essential duties/responsibilities include:

• Support and drive on time completion of investigations, CAPAs, Change controls, etc by closing out QMS documentation following GDP practices.
• Participate in projects within the department as assigned by management.
• Support Quality Systems processes and assist plant wide departments with quality systems process (e.g. Investigations, CAPA, Change Control, etc).
• Revise Standard Operating Procedures as assigned by management.
• Develop and use quality and critical thinking skills.
• Participate in continuous improvement projects.
• Develop understanding of manufacturing processes and quality systems elements.
• Communicate with other managers for process improvements and quality concept.
• Have excellent written and verbal communication skills.
• Perform other duties as assigned.

• Bachelor’s Degree in life sciences or related field is required.
• 0-2 years in GMP related experience in biopharmaceutical/pharmaceutical or related industry.
• Experience with GMP regulatory requirements.
• Organized with paperwork.
• Detail oriented.

The pay range for this position is $48,000 - $57,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.