503B Operations Technician

Description

Job Purpose:

Basic level of understanding the manual packaging processes and necessary preparation, able to participate in all steps of the manual packaging process as well as the ability to assist packaging machines when accompanied by an experienced technician. Provides support to packaging operations as needed.

Essential Duties and Responsibilities:

• Prepare production components for packaging activities.
• Sanitize and inspect materials.
• Perform packaging operations consistent with established protocols, procedures, and cGMP requirements.
• Performs visual inspections of Outsourcing products if deemed necessary or required.
• Assist in inventory control and stocking of supplies.
• Assist with housekeeping and maintenance as appropriate or required.
• Maintain proper documentation of all packaging activities consistent with established GDP policies and procedures.
• Assist with the review of operational procedures as appropriate.
• Practice correct use of PPE and other precautionary measures when packaging product.
• Adhere to GMPs and hold those around them accountable.

Supplemental Functions:

• Visually inspects, labels, and packages for sterile compounded products.
• Manages inventory of production components and prepares components for batch production.
• Perform visual inspection of injectable product in compliance with company policies/procedures, FDA and cGMP regulations.
• Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines.
• Perform additional work duties or responsibilities as evident or required.

Job Specifications and Qualifications:

Knowledge & Skills:

• Knowledge of the Pharmaceutical Industry preferred.
• Must be able to pass a Drug Test.
• Must read, write, and read English
• Must be able to pass and maintain the Visual Inspector Operator Certification.
• Specific expertise, skills, and knowledge gained through education and experience.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches.
• Incumbents required to wear safety glasses, hearing protection, and other not specified protective equipment as necessary.
• Available to work on-call per management’s request.
• Must be able to work well with others.

Working Conditions / Physical Requirements:

• Position required lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.