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Actalent - Roxbury Township, NJ
posted about 1 month ago
Full-time - Entry Level
Roxbury Township, NJ
10,001+ employees
Administrative and Support Services
About the position
The Aseptic Compounder will be responsible for the cGMP manufacturing of sterile pharmaceutical dosage forms. This role involves hands-on work with various manufacturing production equipment and technologies, ensuring compliance with safety policies and good manufacturing practices. The compounder will prepare for production runs, perform batch manufacturing, and maintain documentation in a sterile environment.
Responsibilities
- Ensure all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP), and Standard Operating Procedures (SOPs).
- Prepare for production runs by reviewing the production schedule, identifying batch-specific requirements, weighing and measuring ingredients, and adding them to mixing equipment.
- Gown up to 10 hours per day, four days per week, following aseptic technique experience.
- Report any accidents, incidents, injuries, or illnesses immediately and notify the manager of any hazards, unsafe acts, or conditions in the workplace.
- Update job knowledge by participating in training opportunities and take ownership of individual training plans.
- Review all documentation, including batch records and logbooks, in 'Real Time and Right First Time' and demonstrate error-free documentation. Report any errors or deviations to management immediately.
- Obtain equipment and raw materials for manufacturing and compounding.
- Follow all steps outlined in batch records.
- Perform batch record reviews in real time.
- Operate autoclave and obtain pH measurements.
Requirements
- Experience working in an aseptic environment and the ability to follow aseptic level gowning procedures.
- Knowledge of current Good Manufacturing Practices (GXP) guidelines.
- Experience in compounding, batch testing, and mixing.
- Ability to work with biologics and solutions.
Nice-to-haves
- Gowning/Aseptic Technique Experience.
- Ability to work with other departments and support growth initiatives.
