GMP Aseptic Operator

Ascendia Pharmaceuticals • North Brunswick Township, NJ

391d

About The Position

The GMP Aseptic Operator at Ascendia Pharmaceuticals is responsible for performing manufacturing tasks in the aseptic manufacturing unit processes. This includes operating equipment, weighing manufacturing ingredients, and ensuring compliance with Good Manufacturing Practices (GMP). The role requires participation in safety inspections, documentation of processes, and inventory control, with a focus on producing sterile dosage forms. The operator must be willing to work in rotating shifts and extended hours as needed.

Requirements

• High school diploma is required.
• Bachelor's degree from an accredited institution is preferred.
• Minimum of one year of experience in aseptic pharmaceutical manufacturing required.
• Experience in manufacturing and/or materials handling process is required, including previous experience working with sampling plans, cGMP documentation, and accountability of components, materials, and product.
• Knowledge and experience working in a GMP environment, with good documentation practices, as well as product sampling and inspection.
• Able to read, write, and speak English.
• Knowledge of basic computer software: Word, Excel, PowerPoint, and others if desirable.
• Good communication skills, both verbal and written.
• Able to document legibly, precisely, and clearly in documents following good documentation practices and cGMPs.

Nice To Haves

• Experience in pharmaceutical manufacturing preferred.

Responsibilities

• Manufacture batches on pharmaceutical manufacturing equipment per written batch record procedures, including product sampling and evaluation of in-process data.
• Assist in the maintenance of manufacturing equipment.
• Assemble and disassemble mechanical equipment to execute cleaning tasks and processes as required.
• Clean equipment and maintain the facility according to established procedures and record required information in appropriate logbooks.
• Record and maintain the accountability of APIs, excipients, and components throughout the manufacturing process, including returns of materials and appropriate disposal of waste.
• Complete documentation quickly and efficiently, following good documentation practices, cGMPs, and SOPs.
• Weigh ingredients to be used in the manufacturing of products, including activities related to active ingredients like sieving, subdivision, and intermediate and final formulation.
• Comply with standard operating procedures, batch records, production records, sheets, checklists, and process-related documentation.
• Comply with all training required to perform the tasks, including SOPs, forms, guidelines, and Safety and Environmental training.
• Use personal protective equipment (PPE) required for the process or task to be performed and maintain it in good condition.
• Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notifications of any environmental and/or safety events.
• Perform other related tasks as required.

Benefits

• Health savings account
• Health insurance
• Dental insurance
• 401(k)
• Flexible spending account
• Paid time off
• Vision insurance
• 401(k) matching
• Life insurance

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED