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
A Quality Control (QC) Associate is responsible for verification and archival of study data and departmental records according to established Standard Operating Procedures (SOPs), protocols, methods, and processes. The individual in this role contributes to the team by working independently, completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others.
Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
- Reviews data for adherence to applicable SOPs, methods, protocols, and regulatory requirements.
- Compiles and archives data books and departmental records.
- Reviews methods for accuracy, consistency, and formatting.
- Reviews and issues data sets; compiles data tables using standard reporting templates.
- Maintains established metrics relating to deviations, errors, and laboratory trends.
- Responds to Quality Assurance Audit Database (QAAD) items, as necessary.
Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
- HS/GED with 2 or more years of relevant experience; contract research organization experience preferred.
- Bachelor's/Master's degree with no relevant experience; contract research organization experience preferred.
- Prior experience in a regulated environment and expert knowledge of GxPs and industry guidance documents is preferred.
- Ability to communicate verbally and in writing at all levels inside and outside the organization.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.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.