Support Scientist III

Charles River Laboratories; Shrewsbury (MA); On-site; USD 48,000 - 52,000; Full time

Benefits offered by this job

Bonus incentives

401K

Health coverage

Paid time off

Job summary

Charles River Laboratories in Shrewsbury, MA seeks a QA/Data QC professional to ensure regulatory compliance across assigned studies. You will provide protocol and report support to project scientists and manage sponsor communications.

The role requires strong communication skills, attention to detail, and experience with GLP-regulated data workflows in a lab environment. The pay range is $35.00–$38.00/hour, commensurate with experience.

Qualifications

• Bachelor’s degree required or equivalent in related discipline.
• Three to five years’ experience in biology, chemistry/pharmacy, or similar lab environment; GLP experience preferred.
• Knowledge of GLP regulations and SOPs; strong analytical skills and attention to detail.

Responsibilities

• Create, customize, and monitor planning tools to facilitate prioritization of daily activities (Smartsheet, RPM, M-files, etc.).
• Maintain study and inventory trackers in support of departments.
• Interact with sponsors: send amendments and regulatory forms for signature and respond to sponsor requests for information and tables.

Skills

Analytical thinking

MS Office

Data management

Regulatory compliance

Education

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

Tools

Smartsheet

RPM

M-files

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

Complete understanding of regulatory compliance and assigned department study data/reports. Excellent verbal and written communication skills. Provide protocol and report support to project scientists and information/data requested by sponsors. Assist with management of QA audits and ensure necessary corrections and follow-up take place. Manage multiple studies of varying complexity, concurrently.

Job Description

• Create, customize, and monitor planning tools to facilitate prioritization of daily activities (i.e., Smartsheet, RPM, M-files, etc.).
• Maintain study and inventory trackers in support of departments.
• Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits.
• May serve as primary point of contact to the sponsor when project scientist is not available.
• Efficiently performs and documents QC review of study data and associated audit trails (as applicable), tables, and reports in compliance with applicable regulatory standards, SOPs and company policies, with minimal errors, while identifying processes for improvement. Conducts review of complex QC submissions independently.
• Independently, create/generate special tables and files to support analysis for sponsors, as needed.
• Ensure that all study books are corrected appropriately, and that documentation is compliant prior to submission to QA/data central.

Job Description Continued

• Independently, document deviations from the protocol or Standard Operating Procedures (SOP). Assist in drafting new or study specific SOPs.
• Independently, review and document all study data, procedures, materials and results in compliance with applicable regulatory standards, SOPs, and methods/protocols.
• Maintain a high level of effective communication skills through informal discussions with peers, supervisor, team and Sponsor/Project Scientist.
• Ensure documents align with requirements indicated in Client Information Database (CID).
• Assist with management of QA audits and ensure necessary corrections and follow-up take place.
• On an as needed basis, attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objections, timelines, and reporting requirements, as appropriate for scope.
• Independently develop, review, and update QC guidance documents, SOPs and data check forms. Assist other staff with reviewing and updating documents.
• Assist with generating results, providing study updates and presentation of study data.
• Recommend form and SOP modifications, and changes to standard protocol wording to avoid deviations in collaboration with lab management.
• Develop and oversee periodic training programs with departmental personnel; communicate QC questions, observations, and goals.
• Teach and mentor personnel concerning proper, timely QC practices.
• The pay for this position is between $35.00 - $38.00/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Education And Experience Requirements

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in related discipline required.
• Experience: Three to Five years related experience in biology, chemistry/pharmacy, or similar lab environment. GLP experience preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Knowledge of GLP regulations and understanding of routine study design and protocols.

Physical Requirements

• Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.
• Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
• Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
• Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Move about inside the work area to access file cabinets, office machinery, etc.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

Work Environment

• General office and lab working conditions, the noise level in the work environment is usually quiet.
• While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, work with biohazards.
• The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.
• The noise level in the work environment ranges from low to moderate depending upon the task being performed.
• This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.

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 300 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 20,000 employees within 110 facilities in over 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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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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