Controlled Components Support Specialist

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.

Key Accountabilities

• Daily- 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. 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 packaging components.
• Daily- Stages necessary Components per departmental SOP for the Vialing Packaging, 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 chemical hazards, blood-borne pathogens, etc.
• Understand FDA regulations and ISO standards applicable to department operations 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.

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 perform these operations using units of American money and weight measurement, volume 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

Travel requirements: N/A