Microbiology Data Analyst
Charles River LaboratoriesFor 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
An exciting new opportunity is being created to support our colleagues at the Dublin Endosafe/Celsis Technical Services laboratory.
The Data Analyst, under the guidance of the Laboratory Services Manager, will be required to support the collection, review and analysis of data associated with the testing and other activities related to the Technical Services Department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Continue to perform aspects of the Microbiologist role as needed: LAL Testing (RSE/CSE, QC, customer testing, etc) and Celsis Testing (Consumer Care, Pharma, Adapt, AP etc).
- Continue to develop efficient work procedures and processes that support company and departmental standards and procedures.
- Work side by side with technical service personnel to complete projects and daily work-related items.
- Ensure adherence to pertinent regulatory requirements (cGMP, FDA, ISO) and to departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols].
- Review/update SOPs, protocols and other controlled documents for Technical Service with all pertinent GMP regulations and internal policies.
- Review laboratory testing reports for Celsis studies according to applicable testing proce-dures.
- Review testing related to LAL QC and RSE/CSE determination.
- May be responsible for Initiating, completing, or reviewing Quality documentation associated with change controls, deviations, CAPAs, OOS and lab investigations generated by Technical Service.
- Assist in training as required.
- May participate in inspections and audits.
- Responsible for assisting with and processing product returns and customer complaints.
- Compilation as well as presentation of metrics for processes associated with Technical Ser-vice such as contract testing, complaints, RSE/CSE testing, Service Cloud, quality manage-ment review sessions, tracking and trending meetings, etc. for management on designated frequencies.
- Analyse and Interpret data in order to identify any ‘out of trend’ or early warning indicators. Recommend preventative or corrective action as appropriate.
- Utilise best processes for data review and analysis (E.g. Statistical review, Minitab, PowerBI, etc). Training will be provided as needed.
This is a full time role which based on site primarily within the laboratory, involving the majority of working as part of a dedicated team of eight.
Job Qualifications
Education: Bachelor’s Degree (B.A. /B.S.) in Microbiology / Biology or a related discipline.
Experience: Established post graduation related experience as a Microbiologist supported by an additional track record of related experience in areas such as quality systems, data review, metrics collection and reporting, within a GMP/GLP environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other: Advanced computer literacy required. Proficient with Microsoft Excel. Attention to detail and organisation skills required. Fluency of written and spoken English Language is essential.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.