What are the responsibilities and job description for the Quality Assurance - Associate position at Charles River Laboratories?
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 a Quality Assurance Associate for our Microbial Solutions site located in Charleston, SC.
The Associate Quality Assurance (QA) Auditor is an entry level trainee position. The Associate QA Auditor will perform audits of quality control testing data for routine assays, incoming and in-process materials, process documentation and labeling to assure accuracy and compliance with Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP). Additional responsibilities include: Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality Systems and regulatory requirements for the manufacturing/testing operations. Participate in new employee orientation and associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.
The following are the responsibilities related to the Quality Assurance Associate:
- Participate in review of SOPs and other controlled documents for compliance with all pertinent GMP regulations and internal policies.
- Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with applicable GMPs and Standard Operating Procedures.
- Participate in internal audits of Quality Systems and processes to ensure compliance with GMPs and Standard Operating Procedures, including follow-up on corrective action implementation, and effectiveness.
- Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.
- Determine and assure that exception documentation is appropriately reported and documented.
- Prepare and sign Certificates of Quality related to depyrogenation of accessory products.
- Prepare and review Quality Assurance files prior to Sponsor site visits.
- Perform all other related duties as assigned.
Job Qualifications
The following are the minimum qualifications related to the Quality Assurance Associate :
- Education: Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Other: Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.