Controlled Components Support Specialist

Werfenlife SA.; Norcross (GA); On-site; USD 45,000 - 65,000; Full time

Job summary

Werfen is seeking a Controlled Components Support Specialist for the 1st shift in the United States. You will support vialing, labeling, and packaging activities, ensuring accurate records and adherence to safety rules in a sterile environment.

The role requires a High School Diploma or GED and English proficiency; familiarity with aseptic processes is preferred. This position offers hands-on production work in a global diagnostics company.

Qualifications

• High School Diploma or GED is required.
• Must be able to read, write and speak English.
• Experience in a clean room or aseptic environment is preferred.

Responsibilities

• Daily- perform production tasks following established procedures and work instructions.
• Daily- manage material moves, inventory and counts within the department.
• Daily- document records accurately within required time frames.
• Follow safety regulations and handle hazardous materials per SOPs.

Skills

English proficiency

Attention to detail

Education

High School Diploma or GED

Job description

Controlled Components Support Specialist

Country

United States

Shift

1st

About the Position

Introduction

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.

Overview

Job Summary

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.

Responsibilities

Key Accountabilities

• Daily- Performs task and administrative aspects of production operations according to department procedures, specifications, or work instructions (job orders), calcu-lates 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. Daily- Understands source of products and associated chemical and biosafety hazards.


• Daily- Creates legible written records within procedure/work instruction-defined time frames. Daily- Counts accurately products received, handled, and labeled


• Follow appropriate control measures to prevent mixing dissimilar product packa-ging components.


• Daily- Stages necessary Components per departmental SOP for the Vialing Packa-ging, Labeling, and Solid Phase Department.


• Daily- Order required controlled Components (inserts, glossaries, labels, and other controlled components.


• Daily- Follows applicable laboratory OSHA safety regulations with respect to che-mical hazards, blood-borne pathogens, etc.


• Understand FDA regulations and ISO standards applicable to department opera-tions and the consequences of nonconformance. Daily- Maintains a neat, clean, and orderly work environment. Monthly performs cycle counts as required.


• Daily- Maintain good department morale and employee motivation. Daily—Interact cooperatively with coworkers and supervisors/managers of other departments and receive direction well from superiors.


• As needed, investigate inventory issues and participate in the internal audit process. Move in and out of coolers to retrieve bulks, tanks, carts/trucks with the product, and maintain the coolers' organization.

Networking/Key relationships

Works closely with other production (manufacturing) members, quality control, quality assurance, customer service, shipping, sales and marketing staff.

Qualifications

Minimum Knowledge & Experience required for the position:

• High School Diploma or GED (General Education Diploma) equivalent


• Ability to speak, read and write English


• A WorkKeys Silver Level ACT National Career Readiness Certificate (NCRC), preferred

Skills & Capabilities:

• 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 peform these operations using units of American money and weight measurement, volumd and distance


• List Experience working in an aseptic (clean room) environment, preferred


• 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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.