Microbial Technical Specialist Microbial Technical Specialist

charles river (Neuss NW, Deutschland) Vor 8 Tagen veröffentlicht

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

Process microbial and LAL testing samples in the laboratory utilizing various technology platforms. Provide technical support to customers on instrumentation, sample preparation, submission and interpretation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Assist with product returns and Complaints. Document product complaints as required by the SOP.
  • Perform LAL testing for different studies as assigned encompassing a full range of LAL techniques, gel-clot, kinetic and PTS.
  • Perform IQ, OQ, PQ of lab equipment such as Biotek, PTS and maintains appropriate documents.
  • Perform contract testing laboratories for Celsis and LAL including method development studies, method validation studies, accessory release, CSE/RSE, LAL water etc as required.
  • Perform laboratory activities necessary to isolate, grow and maintain cultures of bacteria.
  • Perform and manage bioburden testing, sterility testing,  membrane filtration and, cleaning validations.
  • Ensure adherence to pertinent regulatory requirements (cGMP, FDA, ISO) and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols.
  • Collaborate with inventory check of laboratory consumables and assist with general housekeeping of the laboratory, performing equipment maintenance and scheduling instrument calibrations.
  • Assist management with development and revision of departmental standard operating procedures and qualification documents.
  • Provide technical assistance/feedback to plant operations to improve product performance as related to compliance requirements.
  • Implement continuous improvement methods to enhance area operations, efficiency and service to both internal and external customers.
  • Perform all other related duties as assigned

Job Qualifications

  • Education: Bachelor’s Degree (B.A. /B.S.) in Microbiology biology or a related discipline.
  • Experience:  2+  years related experience in a pharmaceutical microbiology laboratory setting. 2 years of experience with LAL testing preferred.
  • Other: Knowledge of windows based programs such as word, excel as well as previous experience in using other company specific program applications and a minimum knowledge of algebra. Experience in a cGMP environment preferred.

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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.

For more information, please visit www.criver.com.


Vor 8 Tagen veröffentlicht von charles river - View Original

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