Senior Analyst

Req ID #: 230093

Singapore, SG

Full time

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.

This role is responsible for ensuring the laboratory operations in accordance to ISO 17025 and cGMPrequirements. He/She will serve as analytical lead in variety of projects which includes but notlimited to method validation, method transfer, customized testing activities. In addition, thisindividual is responsible for directing the day-to-day project activity through interaction withtechnical personnel while gathering, analyzing and interpreting scientific data. He/She must ensureaccurate and precise results are being achieved and properly reported.

DUTIES & RESPONSIBILTIES- Provides strong, independent technical leadership to technical personnel
- Leads, designs and performs method development (i.e. bioassay and mycoplasma) andvalidation of new test procedures for incoming projects
- Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
- Evaluates analytical results to form interpretations of data and renders scientific opinions forclient-driven projects
- Serves as technical liaison with Customers with regards to technical services and performsCustomer site visits where required
- Prepares documents including methods, procedures, standard operating procedures (SOP),study protocols, summary reports
- Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements
- Provides problem-solving skills for test procedures and investigations within laboratory unit
- Responsible for notifying Quality Assurance and Senior Management of any compliancedeficiencies or concerns in a timely manner
- Monitors all proficiency-based testing and ensures compliance
- Participates in internal Quality Audits, System Audits, Audits conducted by external agenciesand Regulatory Authorities
- Participates in quarterly management review
- Drives process, quality and safety improvement initiatives within the departmentJob Description: Senior Analyst
- Provides coaching and mentoring to Technical personnel
- Supports the Laboratory Manager in all relevant functions

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

QUALIFICATIONS:

- Bachelor of Science or any related field; MSc. preferred but not essential
- Minimum 2-6 years of relevant QC microbiological experience working in an ISO17025 / GMPlaboratory environment
- Experience in method validation and development, method transfer, qualification activities inregulated laboratory
- Good knowledge of ISO 17025, cGMP and other regulatory guidelines
- Good understanding/working knowledge of Project Management and MeasurementUncertainty (MU)
- 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 dependingon requirement of task on hand

**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.

At Charles River, we