Job Description

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\xe2\x80\x99ll help you build a career that you can feel passionate about.

Job Summary

This role is responsible for ensuring the laboratory operations in accordance to ISO 17025 and cGMP requirements. He/She will serve as analytical lead in variety of projects which includes but not limited to method validation, method transfer, customized testing activities. In addition, this individual is responsible for directing the day-to-day project activity through interaction with technical personnel while gathering, analyzing and interpreting scientific data. He/She must ensure accurate and precise results are being achieved and properly reported.
RESPONSIBILITIES

• Provides strong, independent technical leadership to technical personnel
• Leads, designs and performs method development (i.e. bioassay and mycoplasm) and validation of new test procedures for incoming projects
• Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
• Evaluates analytical results to form interpretation of data and renders scientific opinions for client-driven projects
• Serves as subject matter expert (SME) in area of specialization, established standards for regulatory compliance
• Serves as technical liaison with Customers with regards to technical services and performs Customer 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 compliance deficiencies 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 agencies and Regulatory Authorities
• Participates in quarterly management review
• Drives process, quality and safety improvement initiatives within the department
• Provides coaching and mentoring to Technical personnel
• Supports the Laboratory Manager in all relevant functions

REQUIREMENTS

• Bachelor of Science or any related field; M.Sc. preferred but not essential
• Minimum 2 years of relevant QC microbiological experience working in an ISO 17025 / GMP laboratory environment
• Experience in method validation and development, method transfer, qualification activities in regulated laboratory
• Good knowledge of ISO 17025, cGMP and other regulatory guidelines
• Good understanding/working knowledge of Project Management and Measurement Uncertainty (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 depending on requirements of task on hand