QC Associate-Cellular & Molecular $1000 Sign on Bonus Biology
- Employer
- Charles River Laboratories
- Location
- Mattawan, MI
- Closing date
- Dec 8, 2021
View more
- Sector
- Science, Life Sciences, Pharmaceutical, Quality Assurance
- Organization Type
- Corporate
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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:
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.
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.
- 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.
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.
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