Assay Validation Scientist

Job Description

Assay Validation Scientist Include but are not Limited to the Following:

• Learn new techniques and instrumentation
• Implement assay validation plans, design, and protocols
• Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results
• Keep accurate documentation of all validation project steps according to Eurofins Viracor regulatory guidelines
• Compose and analyze validation data
• Perform peer review of documentation and data
• Assist in writing validation protocols, validation reports, standard operating procedures and study-specific work instructions
• Participate in quality assurance/quality improvement activities. Follows all QC guidelines as stated in the Procedure Manual
• Disposes of bio‑hazardous materials, chemical waste, sharp and other potentially hazardous materials according to Policy
• Accurate pipetting and bench‑level skills (i.e., pipette standard curves to within accurate limits stated in procedure manual)
• Other duties as assigned by management

• Level I – Minimum
• Write standard operating procedures and study‑specific work instructions with minimal assistance
• Write validation plans and reports with minimal assistance
• Assist on establishing clear timelines per assigned projects and coordinating scheduling
• Proficient in multiple platforms and supporting applications
• Ability to successfully multitask more than one assignment at a given time
• Prepare data for presentation at scientific meetings or for client presentations

• Level II – Fully meets the responsibilities of Level I plus the following:
• Leads design and execution of validation projects with little to no assistance from senior management
• Analyzes and interprets data independently
• Independently devises/writes validation plans and project reports
• Obtains advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentation
• Instructs other scientists and leads their development
• As appropriate, communicates with clients within project meetings or independently via email or teleconference

Basic Minimum Work Requirements

Level I – Minimum

• Minimum of 1 year of experience in method/assay validation
• Ability to solve problems, prioritize and multi‑task in a deadline driven environment
• Willing to work with potentially infectious human blood and body fluids
• Must possess skills required for aseptic techniques
• Analytical judgment, problem solving skills, accuracy and strong detail oriented
• Demonstrates a high level of integrity and honesty in performing tests, documenting and maintaining patient, client, employee and laboratory business confidentiality
• High level of proficiency with PC based software program
• Level II – Fully meets the responsibilities of Level I plus the following:
• Minimum of 3 years in method/assay validation
• Possess the required skills to perform the additional level requirements above

Level III – Fully meets the responsibilities of Level II plus the following:

• Minimum of 5 years in method/assay validation
• Possess advanced knowledge and troubleshooting capability
• Advanced communication skills, as demonstrated by successful completion of associate/client presentations or CE coursework in presentations or public speaking
• Possess regulatory knowledge and scientific judgement sufficient to successfully design and lead projects independently
• Authorization to work in the United States indefinitely without restriction or sponsorship

Basic Minimum Education Qualifications

• BS or BA in Biology, Microbiology, Clinical Laboratory Science, Chemistry or a relevant field

Physical Requirements

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to stand for extended periods of time as necessary in the laboratory (4 or more hours)
• Ability to lift and move…