Controlled Components Support Specialist

Werfen•Norcross, GA

8d•Onsite

About The Position

Performs various tasks and duties to ensure the appropriate day-to-day support for the operations of the Vialing, Labeling, Packaging, and Solid Phase Departments. Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Requirements

High School Diploma or GED (General Education Diploma) equivalent
Ability to speak, read and write English
Ability to deal with problems involving a few concrete variables in standardized situations
Ability to add and subtract two-digit numbers and to multiply and divide with 10s and 100s. Ability to perform these operations using units of American money and weight measurement, volume and distance
Ability to constantly use hands to place product on and remove product from wheel and visually check product
Ability to use ladder to reach product/supplies
Ability to maneuver Serum carts weighing approximately 700 pounds in and out of coolers
Ability to stand for over intervals of several hours at a time
Ability to check for defects, check fill levels, and identify and distinguish between colors to help verify dropper assembly

Nice To Haves

A WorkKeys Silver Level ACT National Career Readiness Certificate (NCRC), preferred
Experience working in an aseptic (clean room) environment, preferred

Responsibilities

Performs task and administrative aspects of production operations according to department procedures, specifications, or work instructions (job orders), calculates component usage, and verifies counts of products in and out of operation.
Moves, stores, and inventories of products and controlled components according to department specifications.
Understands source of products and associated chemical and biosafety hazards.
Creates legible written records within procedure/work instruction-defined time frames.
Counts accurately products received, handled, and labeled.
Follow appropriate control measures to prevent mixing dissimilar product packaging components.
Stages necessary Components per departmental SOP for the Vialing Packaging, Labeling, and Solid Phase Department.
Orders required controlled Components (inserts, glossaries, labels, and other controlled components).
Follows applicable laboratory OSHA safety regulations with respect to chemical hazards, blood-borne pathogens, etc.
Understands FDA regulations and ISO standards applicable to department operations and the consequences of nonconformance.
Maintains a neat, clean, and orderly work environment.
Performs monthly cycle counts as required.
Maintains good department morale and employee motivation.
Interacts cooperatively with coworkers and supervisors/managers of other departments and receives direction well from superiors.
As needed, investigates inventory issues and participates in the internal audit process.
Moves in and out of coolers to retrieve bulks, tanks, carts/trucks with the product, and maintains the coolers' organization.
Works closely with other production (manufacturing) members, quality control, quality assurance, customer service, shipping, sales and marketing staff.