Use our `search` to find similar offers.
QC Analyst Lead Microbiology - Sun - Wed, 7:30am - 6pm
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Job Summary
The QC Analyst Lead Microbiology provides essential support to manufacturing by leading in conjunction with the Laboratory Supervisor, with a deep understanding of environmental monitoring principles and laboratory testing, including Endotoxin, Mycoplasma, Sterility, and growth promotion, the Lead Analyst serves as a backup to the supervisor, performs qualification testing, trains staff, manages supplies, reviews data accurately, and contributes to data analysis and reporting. This role plays a pivotal part in maintaining efficiency and compliance while collaborating across departments to ensure the timely and successful execution of project activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Serves as acting supervisor during the absence of the QC Laboratory Supervisor • Serves as subject matter expert of environmental monitoring program and/or laboratory testing. Including, but not limited to: Endotoxin, Mycoplasma, Sterility, and grown promotion. • Performs qualification testing for laboratory assays or environmental monitoring • Performs extensive training for specific testing and environmental monitoring activities • Orders, receives, and stores EM and laboratory supplies • Accurately reviews and approves laboratory data • Participates in scheduling tasks • Performs data/statistical analysis, data trending, reporting results and presenting data in group and client meetings. • Contribute to drafting Standard Operating Procedures (SOPs), protocols, reports, etc. May write deviations, EARs, OOS reports, CAPAs. • Participates in company sponsored training • Interact closely with other departments to ensure efficient, compliant and timely execution of project activities • Perform all other related duties as assigned.
Job Qualifications
• Bachelors or higher degree in the biological sciences or related field preferred • Minimum of 3-5 years of relevant laboratory experience in a cGMP and/or FDA regulated industry OR a combination of 5-7 years of education and laboratory experience in a cGMP and/or FDA regulated industry • Demonstrated extensive knowledge in Microbiology and aseptic techniques required • Extensive Aseptic technique/handling • Experience with writing complex laboratory reports, investigations, etc • Demonstrate strong leadership skills in a microbiological laboratory setting • Detail oriented with strong written and verbal communication skills • Experience with training laboratory personnel
PREFERRED QUALIFICATIONS:
• Prior pharmaceutical, CMO, CDMO and hazardous goods experience • Familiar with laboratory data systems such as MODA, LIMS, etc • Gown Qualification/Gown Certification Experience • Experience with Microsoft Word, Excel and Outlook
Compensation Data
The pay range for this position is $32.70 - $35.10. 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 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, or 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 [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Job posted: 2024-03-07
