SUMMARY
Assists in the development, validation, product transfer, manufacturing, quality control, and maintenance of diagnostic tests for the Clinical Laboratory. Previous experience in IVD manufacturing preferred.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Team member to assist in the development and launch of novel diagnostic tests and technical support of existing tests
• Takes direction from management and senior staff to meet project goals and timelines
• Works with senior staff to devise and perform development, optimization, investigation, and new technology assessment studies
• Works with senior staff for the design & development, establishing of specifications, validation & verification, design & process transfer, manufacturing & quality control testing, launch & implementation activities to include post-launch monitoring, maintenance & troubleshooting
• Author and/or revise SOPs, forms, policies, batch records, proposals, reports, investigations, and notebook write-ups
• Analyze data with senior staff using complex algorithms and methods in statistical analysis to draw conclusions with recommendations for implementation
• Supports databases for the quality control of diagnostic tests, clinical samples, analytical studies, and clinical studies
• Creates and maintains clinical data as needed
• Provides summary reports and give presentations to senior staff and project teams
• Complies with CAP/CLIA requirements, safety and other guidelines as needed

SUPERVISORY RESPONSIBILITIES

This job has no supervisory responsibilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Position generally requires a BA/BS degree in the biological and life sciences with 5-8 years product development and/or laboratory experience or a MS in the biological and life sciences with 2-5 years of product development and/or laboratory experience. Must have hands on experience preparing reagents and performing immuno- and/or nucleic acid assays such as ELISA, HPLC, and SNP assays. Experience with diagnostics, automation, and validation of analytical methods is preferred. Experience working in GLP/GMP/FDA and/or CLIA/CAP regulated atmosphere is preferred.

LANGUAGE SKILLS

Ability to read and analyze professional journals, technical procedures, and governmental regulations is required. Ability to write reports, business correspondence, procedure manuals, and SOPs. Ability to effectively present information and respond to questions.

MATHEMATICAL SKILLS

Ability to apply mathematical concepts and operations to test reliability and validity of data. Proficiency in Excel is required.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical instructions in mathematical, written or diagram form

CERTIFICATES, LICENSES, REGISTRATIONS

None required.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 55 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.