Job Description

For 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.
POSITION SUMMARY
This role is responsible for technical laboratory activities in support of client studies or procedures. He/She will perform analysis of data for quality and completeness and determine if results are as expected. He/She will be responsible for recording of data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements, and ensuring compliance with protocols and all applicable SOPs.
DUTIES & RESPONSIBILITIES

• Performs all laboratory functions as tasked with high degree of accuracy and strict adherence to Company's quality requirements.
• Maintains proper records that are compliant with good documentation practices (GDP) and data integrity requirements, for all testing and test-related activities (e.g. raw data sheets, usage log books, and all other records).
• Generates reports for all tests performed in an accurate and timely manner, ensuring that targets are met for accuracy and turnaround time.
• Performs good housekeeping and maintenance of the laboratory, especially in the area of responsibility.
• Prepares client test protocols, facilitates training of other analysts for the approved client test protocols, and updates protocol database.
• Generates or revises standard operating procedures (SOPs) relating to area of responsibility during routine document review or when there is a regulatory update.
• Participates in investigations (e.g. root cause analysis, impact analysis, risk assessment, corrective action, etc.)
• Contributes significantly to the activities of the assigned technical committee, as per the duties and responsibilities designated to the committee.
• Provides support during external and internal audits for the areas of responsibility.
• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
• Participate in method development and validation of routine and customised testing services.
• Participate in the establishment of customised routine testing services and validations that are in compliance with the latest regulatory and/or customer requirements.
• Conducts test demonstrations to clients during site visit or when necessary.
• Documents and reports to immediate superior any event that has occurred at the laboratory which could, in his/her reasonable opinion, potentially result in a hazardous, litigious or quality-compromising situation.
• Adheres to Company Policies and Procedures.
• Ensures relevant Health and Safety requirements are adhered to, including undertaking any mandatory training as required.
• Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.

General requirements

• Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.
• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
• Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
• Performs all other related duties as assigned.

QUALIFICATIONS:

• Bachelor of Science or any related field; Diploma in related field would be considered.
• Minimum 2 years of relevant QC microbiological experience working in an ISO17025 / GMP laboratory environment
• Good knowledge of ISO 17025, cGMP and other regulatory guidelines
• Good technical understanding and judgement
• Good interpersonal and communication skills across cultures
• Team player with ability to work in cross-functional teams as well as independently depending on requirement of task on hand

About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.
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.
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.

Skills Required