Validation Scientist II

Labcorp•Indianapolis, IN

2d•Onsite

About The Position

The Validation Scientist II will organize and perform method validation testing with relative independence and efficiency, ensuring compliance with methods, protocols, SOPs, and regulatory agency guidelines. This role involves executing advanced validation activities with guidance, displaying intermediate data interpretation and analytical instrumentation skills, and troubleshooting procedural and scientific issues with minimal assistance. The scientist will also assist in reviewing reports, methods, protocols, and SOPs, maintaining complete study documentation, and informing management of any issues affecting data integrity. Additionally, the role includes managing assigned projects, coordinating work with team members, training less experienced staff, participating in process improvement initiatives, supporting client communications, and reviewing the work of others for accuracy and soundness of technical judgment. A clean and safe laboratory work environment must be maintained.

Requirements

Bachelor’s Degree in chemistry, biology, molecular biology, immunology, biochemistry, etc.
2 years or more of experience with validation testing, regulatory agency guidelines and SOP’s
2 years or more of experience with standard laboratory equipment and analytical instrumentation (e.g., balances, pipettes, centrifuges) including problem identification and resolution
2 years or more experience of Independently conducting tests and providing initial analysis of results
2 years or more experience in various study types, analysis procedures, and methodologies
2 years or more experience Identifying process improvement opportunities, recommending solutions, and implementing action plans
Able to effectively communicate, both verbally and in writing
Effectively interacts with internal and/or external clients
Completes project assignments on time with minimal/no supervision

Nice To Haves

Master’s Degree in chemistry, biology, molecular biology, immunology, biochemistry, etc.
2 years or more experience with ELISA-based platforms and related instrumentation (e.g. ELISA, Meso-Scale Discovery™, Hamilton™ Liquid Handling Immunoassay modular automation, etc.)
2 years or more evaluation of data for incorporation into written reports
1 year or more Maintenance and troubleshooting of equipment training
Understands and helps staff with compliance with SOPs and other regulatory agency guidelines

Responsibilities

Organizes and performs routine to moderate level of method validation testing (and all associated activities) with relative independence and efficiency in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines
Capable of executing advanced level of method validation activities with guidance
Displays intermediate data interpretation and analytical instrumentation skills and works through procedural and scientific routine problems and issues with minimal assistance
Assists in review of reports, methods, protocols, and SOPs and maintains complete study documentation in compliance with regulatory guidelines (e.g. GLP and GCP) and department processes
Informs Lead Scientist and/or management of any problems and/or deviations that may affect integrity of the data; participates in corrective action of problems
Manages work on assigned projects each week, and coordinates work activities with team members to deliver data (right the first time) to internal clients
Effectively interacts with colleagues within the bioanalytical site
Trains and assists less experienced staff
Participates in process improvement initiatives
Supports communications with external clients and other team members
Able to review the work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment
Maintains a clean and safe laboratory work environment
Performs other related duties as assigned