Validation Scientist III

Labcorp • Madison, WI

27d • $50,000 - $80,000 • Onsite

About The Position

Are you looking to take your career to that next step? The Validation Scientist III - Performs method validation, method update and stability testing using a variety of analytical techniques in compliance with standard operating procedures (SOPs) and regulatory agency guidelines. Provides downstream support of methods to associated groups. Serves as a bioanalytical resource to the broader business. Essential Job Duties: Organizes and performs routine to advanced level of method validation/testing (and all associated activities) with independence and efficiency in compliance with appropriate SOPs and regulatory agency guidelines. Capable of moderate level of method development with guidance. Displays advanced data interpretation and analytical instrumentation skills and responds to difficult procedural, technical and quality questions with minimal guidance. Assists in writing and 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 the integrity of the data and recommends corrective action. Writes and reviews training materials and delivers training/mentorship of staff in relevant techniques, procedures and provide expert advice on training requirements. Supports communications with external clients and other team members. Participates in new equipment, instrument and methodology assessment and qualifications Demonstrates advanced time management skills and manages work on multiple assigned projects in a given week, and liaise and coordinate work activities with team members in order to deliver data (right first time) to internal clients. Support others in their duties to ensure all scheduled operational activities are completed on each given day by effective and concise communication with team members, and ability to listen and discuss ideas in an open and professional manner. May interact in external client communications. Maintains a clean and safe laboratory work environment, sets example for self and others. Participates in process improvement initiatives. Developed as an expert in a key process/area for the department. Performs other related duties as assigned Experience: Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges). Experience with use and troubleshooting of analytical equipment. Independently conduct tests for chemistry projects and provide initial analysis of results. Acts as a technical resource for the department (trouble shooting, method development, qualification, maintenance and training). Maintains and operates laboratory equipment, including independent problem identification and resolution. Evaluates data for incorporation into written reports. Completes project assignments on time with no supervision. Understands and helps staff with compliance to SOPs and other regulatory agency guidelines. Identifies process improvement opportunities, recommends solutions and implements action plans. Knowledgeable on a variety of study types, analysis procedures and methodology. Able to effectively communicate, both verbally and in writing. Effectively interacts with internal and/or external clients. Acts as a project leader. Ability to assist in the preparation of relevant sections of final reports. Knowledgeable on a variety of study types, analysis procedures and methodologies.

Requirements

• Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).
• Experience with use and troubleshooting of analytical equipment.
• Independently conduct tests for chemistry projects and provide initial analysis of results.
• Acts as a technical resource for the department (trouble shooting, method development, qualification, maintenance and training).
• Maintains and operates laboratory equipment, including independent problem identification and resolution.
• Evaluates data for incorporation into written reports.
• Completes project assignments on time with no supervision.
• Understands and helps staff with compliance to SOPs and other regulatory agency guidelines.
• Identifies process improvement opportunities, recommends solutions and implements action plans.
• Knowledgeable on a variety of study types, analysis procedures and methodology.
• Able to effectively communicate, both verbally and in writing.
• Effectively interacts with internal and/or external clients.
• Acts as a project leader.
• Ability to assist in the preparation of relevant sections of final reports.
• Knowledgeable on a variety of study types, analysis procedures and methodologies.
• Bachelor’s Degree + 3 years of relevant work experience and/or
• Master’s Degree + 1-2 years of relevant work experience
• Relevant Bioanalytical experience may be substituted for education
• Ability to perform basic computer skills (e.g., Word, Excel)

Responsibilities

• Organizes and performs routine to advanced level of method validation/testing (and all associated activities) with independence and efficiency in compliance with appropriate SOPs and regulatory agency guidelines.
• Capable of moderate level of method development with guidance.
• Displays advanced data interpretation and analytical instrumentation skills and responds to difficult procedural, technical and quality questions with minimal guidance.
• Assists in writing and 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 the integrity of the data and recommends corrective action.
• Writes and reviews training materials and delivers training/mentorship of staff in relevant techniques, procedures and provide expert advice on training requirements.
• Supports communications with external clients and other team members.
• Participates in new equipment, instrument and methodology assessment and qualifications
• Demonstrates advanced time management skills and manages work on multiple assigned projects in a given week, and liaise and coordinate work activities with team members in order to deliver data (right first time) to internal clients.
• Support others in their duties to ensure all scheduled operational activities are completed on each given day by effective and concise communication with team members, and ability to listen and discuss ideas in an open and professional manner.
• May interact in external client communications.
• Maintains a clean and safe laboratory work environment, sets example for self and others.
• Participates in process improvement initiatives.
• Developed as an expert in a key process/area for the department.
• Performs other related duties as assigned

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level