Manufacturing Product & Packaging Operator I (Manufacturing)

Description:

The Manufacturing Product and Packaging Operator I plays a vital role in the daily production of medical devices, ensuring compliance with current Good Manufacturing Practices (cGMPs), customer requirements, and Standard Operating Procedures (SOPs). Responsibilities include reviewing batch records and amendments, setting up and verifying calculation data, preparing and verifying test materials before dose administration, and accurately performing procedures with proper documentation. This entry-level role operates under direct supervision, following established procedures to execute production and meet project deadlines.

Essential Functions:

• Completes a variety of assignments under direct supervision based on established procedures including performing experiments to pilot/scale-up/ANDA batches and process optimization of oral dosage form unit operations using FDA's quality by design and well-experimental design approaches.
• Summarizes data in reports; records document experimental work/in-process testing accurately utilizing established best practices.
• Communicates with good writing and critical analysis skills and presents process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors.

Additional Responsibilities:

• Responsible for all applicable documentation, creating and maintaining activity records and requirements.

 

Education:

• High School or GED - Required
• Associate Degree High School or Above - Preferred

Experience:

• 1 year or more in Pharmaceutical development and manufacturing.

Skills:

• Possesses advanced technical skills, time management, communication and a commitment to innovation and efficiency. 
• Is up-to-date on recent advances of manufacturing equipment and operation.
• Strong communication and problem-solving skills. 
• Team-oriented with the flexibility to adapt to changing work priorities. 
• Willingness to work flexible hours, including weekends, as needed. 
• Must possess good computer skills.
• Ability to generate, review and generate batch records

Specialized Knowledge:

• Working knowledge of techniques and equipment related to pharmaceutical manufacturing of medical devices. 
• Ability to perform in-process tests such as loss on drying, disintegration bulk and tap density and sieve analysis, hardness, thickness, friability, weighing.
• Knowledge of performing calculations required in batch records
• Understanding and application of cGMP requirements 
• Knowledge and adherence to applicable state and federal laws and the safe usage of chemicals as identified in the MSDS.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.