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Charles River Laboratories Quality Assurance Supervisor in Shrewsbury, Massachusetts

Quality Assurance Supervisor

Req ID #: 96092

Location:

Shrewsbury, MA, US, 01545

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.

Job Summary

We are seeking an experiencedQuality Assurance Supervisor for our Safety Assessment site located inShrewsbury, MA.

TheQuality Assurance Supervisorwill Supervise and provide support in the management of daily work flow operations of Quality Assurance (QA) staff. Perform audits of protocols, raw data and final reports of all complexity levels Perform inspections of laboratory operations and facility. Coordinate and participate in QA assignments for audits in areas such as computer validation and subcontractor and vendor audits.

Essential Duties and Responsibilities

  • Provide management support with day to day QA departmental operations.

  • Assist in the development, maintenance and communication of departmental systems and SOPs.

  • Assist or host client QA site visits.

  • Prepare and assure Quality Assurance files and records are available for Sponsor site visits.

  • Coordinate and identify training and development needs of direct reports.

  • Oversee main­tenance of group training manual and training records.

  • Coordinate and implement company-wide GLP training sessions.

  • Review protocols for compliance with all pertinent governmental and international regulations

  • Inspect in-life critical phases of ongoing studies for compliance with the study protocol and Standard Operating Procedures.

  • Review raw data for ongoing studies for accuracy and compliance with the study protocol and Standard Operating Procedures.

  • Review final reports for accuracy and compliance with appropriate regulations.

  • Assist in other Quality Assurance functions such as facility inspections, Standard Operating Procedure updates, archival duties and inspection of subcontractors..

  • Assist in audits conducted at other facilities on a consultant basis.

Job Qualifications

• Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.• Experience: Minimum of 5 years in QA or in a GLP environment. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.• Certifications/Licensure: RQA (GLP).• Other: Clear understanding and knowledge of Good Laboratory Practice Regulations (US and International). Experience with word processing and spreadsheet programs such as Word, Access, and Excel. Must possess effective communication skills in order to gain cooperation from others.

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.

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 17,000 employees within 90 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 85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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.

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