Sr. QC Project Analyst
Charleston, SC, US, 29407
For nearly 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 Microbial Solutions team located in Charleston, SC is seeking a Senior Quality Control Project Analyst.
This is a full-time; Monday - Friday position.
This role will ensure the quality and integrity of products through testing. Drafts testing procedures and protocols, schedules and maintains long-term stability, and performs administrative functions. Attention to detail in all aspects of work is essential.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Compliance with Standard Operating Procedures, Specifications, Good Manufacturing
Practices, and company policy.
• Responsible for documentation as required by cGMP and FDA regulations.
• Proficient in all aspects of Quality Control testing.
• Proficient in documenting, investigating, and performing operational review of product excursions.
• Reviews Quality Control data.
• Reviews Controlled Documents such as Standard Operating Procedures and Specifications.
• Orders and maintains laboratory supplies.
• Drafts new Standard Operating procedures.
• Computer System administration.
• Performs non-routine maintenance of equipment.
• Drafts and assists in the execution of protocols.
• Drafts laboratory notebook studies.
• Places lots on long-term stability and maintains testing schedule.
• Oversees product validation testing completion and maintains appropriate documents.
• Works with QC supervisors to schedule projects and ensures their completion.
• Performs testing to support the long-term stability program and summarizes testing data.
• Interacts with customers to support customer audits.
• Performs general housekeeping and adheres to safety procedures.
• Performs other related duties as assigned.
Job Qualifications
• Education: Bachelors degree (BA/BS) in a scientific discipline or related field.
• Experience: Experience with GMP products and laboratory operations required.
• Certification/Licensure: None
• Other: Computer literacy must include word processing, spreadsheet, and math skills.
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.
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 supported the development of 86% of the drugs approved by the FDA in 2021.
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, national origin, veteran or disability status.
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Nearest Major Market: Charleston South Carolina
Nearest Secondary Market: South Carolina
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