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PURPOSE AND SCOPE:

Performs laboratory testing of pharmaceutical products, medical devices and/or raw materials that are commensurate with the experience and education displayed from effective utilization of laboratory knowledge and equipment.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

+ Under supervision, utilizes established procedures to perform routine assigned laboratory testing.

+ Proficient in the operation of laboratory instrumentation and equipment.

+ Maintains accurate, detailed records of work performed.

+ Monitors and corrects housekeeping deficiencies in the laboratory.

+ Notifies laboratory management when unusual results or data deviations occur.

+ Writes, updates, and evaluates test methods and SOPs.

+ Provides guidance to other laboratory personnel in general laboratory practices under the direction of laboratory management.

+ Assists in test method development, validation, and verification for new and existing products.

+ Creates technical reports of tests and studies.

+ General knowledge of USP and ISO guidelines as they pertain to product quality.

+ May refer to senior staff if applicable, for assistance with day-to-day problems that may arise.

+ Escalates issues to supervisor/manager for resolution, as deemed necessary.

+ Assist with various projects as assigned by direct supervisor.

+ Other duties as assigned.

_Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions._

PHYSICAL DEMANDS AND WORKING CONDITIONS** **:

+ The physical demands and 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.

+ Regularly required to use hands and fingers to handle; talk or hear and wear personal protective equipment that may include Safety glasses, etc.

+ Frequently required to stand; walk; sit; reach with hands and arms and climb or balance. The employee is occasionally required to stoop, kneel, crouch, or crawl.

+ Must be able to lift and/or move up to 50 lbs.

+ Occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; extreme cold; extreme heat and risk of electrical shock.

+ The noise level in the work environment is usually moderate.

SUPERVISION:

+ None

EDUCATION** **:

+ Bachelor's Degree in science related field. Microbiology preferred.

EXPERIENCE AND REQUIRED SKILLS:

+ 0 - 2 years' related experience.

+ Basic knowledge of laboratory science.

+ Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

+ Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

+ Simple algebraic computations and routing statistical calculations may be required.

+ Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

+ Ability to deal with problems involving several concrete variables in standardized situations.

+ Strong oral and written communication skills.

+ Strong computer skill, proficiency with Microsoft Office applications.

EO/AA Employer:** **Minorities/Females/Veterans/Disability/Sexual** **Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans