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
The QA Specialist II is responsible to ensure that production process is client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements. The QA Specialist II will compile the batch record review records and batch disposition documents required for GMP operation on timely basis.
Key Responsibilities and Duties:
• Provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance, plasmid products and/or final drug product used for human consumption
• Support Manufacturing and quality control departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs)
• Track and evaluate any non-conformances that occur during the manufacture of drug product and evaluate change controls as they impact the project
• Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
• Review executed batch production records and associated supporting documentation including logbooks, QC test reports, Environmental monitoring reports, cleaning records, etc.
• Compile batch disposition documentation timely for the final disposition of finished products
• Perform QA on the floor activities supporting client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
• Support raw materials review and disposition following approved internal procedure
• Receive and issue Batch Production Records and labels to manufacturing departments by verifying the accuracy and completeness from QA Document Control
• Ensure SOPs are current and effective, and staff performs routine tasks according to SOP through direct observation
• Review quality control test reports related to the execution of the batch processing
• Train Level 1 QA Specialists as required
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
• Actively participate in all recruiting efforts to secure, onboard, and develop new staff members
• Evening and weekend hours may be needed to support production operations
• Additional duties as assigned
Job Qualifications
• BS/ BA in life sciences or related fields
• Minimum 5 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry
• Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines
• Previous experience in TrackWise Digital and Pilgrim is a plus
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
• Strong verbal and written communication skills
• Strong organizational skills; able to prioritize and manage through complex processes/projects
• Ability to define problems, collect data, and draw valid conclusions
• Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment
• Organized, responsible, creative, pays attention to detail
• Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint)
• Able to follow instructions and Standard Operating Procedures
Compensation Data
The pay range for this position is $87,733 – $116,978 annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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 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 [email protected]. 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.
Helping you find your moment
You take great care and effort when you apply for a job with us. Rest assured that we’ll be just as diligent in finding the role that’s right for you. Here’s how our hiring process works:
Job Search
Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.
Application
Create a profile and apply to as many roles as you have an interest.
Note: Depending on the role, you may be required to include a resume in your application.
Assessment and application review
Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.
Note: At any point in the process, you can log into your profile to review the status of your application.
Interview
Engage in our interview process by meeting with a group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions and better understand how we foster a sense of belonging at Charles River.
Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.
Job offer and onboarding
Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information.
Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.
Job Search
Learn about CRL, our culture, and why we do the work we do while also searching for roles that match your interests and expertise.
Application
Create a profile and apply to as many roles as you have an interest. Note: Depending on the role, you may be required to include a resume in your application.
Assessment and Application Review
Complete assessments, if requested, to determine whether the role is likely to be a good fit for you – and vice versa. The recruiter will review your resume and qualifications against the requirements of the role and will determine next steps.
Note: At any point in the process, you can log into your profile to review the status of your application.
Interview
Engage in our interview process by meeting with a group of interviewers who will provide information on the company, culture, and your role while also asking you questions to assess your skills, interests, and expertise. This is also a great time for you to ask questions and better understand how we foster a sense of belonging at Charles River. Note: Charles River leverages technical and behavioral-based interview questions based on our DNA (Care, Lead, Own, and Collaborate). Please familiarize yourself with the DNA and be prepared to relate your experiences to them.
Job offer and onboarding
Receive a competitive offer either by phone or email from a Charles River recruiter or hiring manager. The offer will include your title, salary, location, and other relevant information. Note: Upon acceptance, you will work with your recruiter to confirm a start date and will receive paperwork to electronically complete prior to your start. For US-based roles, upon your acceptance, you will be required to take a pre-employment drug screen and pass a criminal background check.
Featured jobs
Important things are happening every moment at Charles River. This means exciting new career opportunities for you to explore. Take a look and apply today!
Looking for something else? Search all jobs.
Moment by moment
At Charles River, you’ll be able to contribute to incredible breakthroughs while experiencing exciting opportunities for growth and development.
-
UX/UI Designer
Advocate for user-centered design solutions. Create distinctive, consistent, branded digital experiences across multiple platforms, devices, and channels.
-
Senior UX/UI Designer
Define and drive UX/UI strategies and interaction designs – from scratch and for scale – that solve business and user problems.
-
Associate Director
Work with Senior UX/IX Designers and developers to assess problems and develop solutions. Execute on plan by building coding standardizations and automating processes.
-
Director, Digital Data Enablement
Lead UX management and operational teams across business units and technical teams. Identify and define fit-for-purpose strategies to integrate best practices.
-
Senior Director UX/UI Design
Mentor, coach, and guide designer teams on design strategy related to research insights, execution, continuous integration, and automated deployment.
-
-
Animal Care Technician I - V
Maintain the well-being of our animals by providing food, water, and a clean environment.
-
Animal Care Technologist I - V
Provide specialized care to maintain and monitor our animals’ health and physical environment.
-
Veterinary Technician
Help monitor, document, and triage all laboratory animal health cases.
-
Team Leader / Supervisor
Supervise, train, mobilize, empower, and develop a high-performing team.
-
Research Associate
Coordinate and plan activities according to study plan guidelines.
-
-
Intern Level I
Support process/procedure improvement based on site and department needs. Gain knowledge of our corporate environment to navigate cross-functional department collaboration.
-
Intern Level II
Complete comprehensive departmental projects incorporating mentorship of Level I interns as a professional development component.
-
Biomanufacturing Technician I-III
Oversee the production, formulation, and banking of cellular products while maintaining compliance with GMP, GDP, and aseptic guidelines.
-
Biomanufacturing Lead / Specialist
Maintain in-depth knowledge of specialized equipment to address questions as a Subject Matter Expert for the required equipment.
-
-
Clinical Veterinarian I-III
Responsible for delivering professional veterinary services and helping to manage all phases of health care for the animal colony.
-
Senior Clinical Veterinarian
Utilize knowledge of laboratory animal medicine to optimize the scientific objectives of animal research protocols.
-
Principal Veterinarian / Associate Director
Conduct veterinary consults, make treatment recommendations, communicate with study directors, and follow cases through resolution.
-
Director, Laboratory Animal Medicine
Provide technical and professional oversight of all animal care and use functions involving site laboratory animals.
-
-
Technician I-III
Follow SOP and protocols in the areas of animal handling, husbandry, and blood/urine collection.
-
Technician IV-V
Handle advanced technician duties, including anesthesia, leadership and specialized sample collections.
-
Project Leader (Scientific)
Serve as a scientific expert for the Lab with responsibility for staff-conducted studies.
-
Team Leader (People Leader)
Oversee team activities and gain leadership skills on the path to becoming a Team Supervisor.
-
Team Supervisor (People Leader)
Responsible for overall employee supervision, staff development, and team success.
-
-
Financial Analyst I
Help analyze financial data, extract/define relevant information, and interpret data.
-
Financial Analyst II
Responsible for analysis, forecasting, budgeting, accounting administration, and reporting of projects.
-
Senior Financial Analyst
Handle weekly and monthly forecasting and annual budget preparation. Prepare financials and key indicators for business reviews.
-
Manager, Business Finance
Partner with operating businesses to raise standards in key decision areas. Present a dynamic industry, competitor, and economic context.
-
Finance Director, Operations
Support all business aspects, working with site teams to direct weekly/monthly forecasting and annual budget preparation.
-
-
Biomanufacturing Technician I
Support the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing).
-
Biomanufacturing Technician II
Perform specialized activities in the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing). Train Biomanufacturing Technician 1.
-
Biomanufacturing Technician III
Help advance the production, formulation, and banking of novel cellular products (including cGMP, GDP, and aseptic processing) while interacting with clients.
-
Biomanufacturing Lead / Specialist
Maintain in-depth knowledge of specialized equipment to address questions as a Subject Matter Expert for the required equipment.
-
Biomanufacturing Supervisor
Oversee biomanufacturing personnel, ensuring compliance with cGMP’s, CRL quality systems, and process documents in biomanufacturing.
-
Biomanufacturing Manager
Lead biomanufacturing activities in the start-up and cGMP production of novel cellular products. Schedule and manage staff, ensuring a safe and compliant working environment.
-
-
Client Manager
Ensures high-quality customer service through multi-site coordination. Deliver timely, accurate, and comprehensive responses to sponsor requests.
-
Business Development Director
Deliver profitable sales growth by targeting and visiting clients to build strong relationships and customer loyalty.
-
Senior Business Development Director
Plan and execute a territory-based field sales strategy. Drive growth through targeted long- and short-term account plans.
-
Regional Sales Manager
Manage sales team within North America's Safety Assessment sales region to achieve sales and profit goals.
-
-
Director
Partner with site leadership to achieve performance goals, develop staff, and deliver succession planning.
-
Senior Director / General Manager
Lead a multi-functional team to ensure integrated operations. Collaborate with senior leadership to form plans, objectives, and policies.
-
Executive Director
Lead a global, multidisciplinary team. Develop short and long-term strategic plans to maximize growth and profitability.
-
Corporate Vice President
Provide leadership, direction, and advice to leadership and finance teams. Accountable for financial planning, directing, and controlling.
-
About Charles River
Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions around the world.
Supporting your well-being
Your dedication and passion make a life-saving difference in lives around the world. We’re committed to providing you with benefits that elevate your quality of life.
Financial
- Earnings + incentives
- Retirement benefits
- Vacation + time away
- Recognition
- Employee assistance fund
Career
- Professional development opportunities
- Career development
- Awards
- Educational support
Health and wellness coverage
- Employee well-being support
- Family support programs
- Parental benefits + family formation benefits
- Work-life balance flexibility
Social and Community
- Culture of belonging
- 11 employee resource groups (ERGs) with >4,000 members, where all employees are welcome
- Opportunities for paid volunteer time off
- Community outreach + matching gift + engagement activities
About Charles River
Charles River is an early-stage Contract Research Organization (CRO). Here, we are passionate about our role in improving the quality of people’s lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions around the world.