Job Description:

·         Incumbent will be responsible for all aspects in solid dosage manufacturing of product to ensure compliance with cGMPs, SOPS, FDA, and DEA guidelines. 

·         Operates production equipment required to manufacture solid dose pharmaceutical controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines. 

·         Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.

·         Completes accurate and timely documentation to comply with FDA and GCP/GLP/GMP regulations.  

·         Performs calculations, critical measurements and weights for production needs as stated in the Manufacturing Batch Record.

·         Uses computer systems to enter batch data, review Standards Operating Procedures (SOPs), and operate computerized manufacturing equipment.

·         Adheres to all regulatory guidelines including execution of supporting product documentation.

·         Uses knowledge of pharmaceutical processes and associated production equipment to solve production and process problems.

 Required Skills/Experience:

·         Associates or Bachelor degree with 2+ years cGMP pharmaceutical operations experience OR,

·         HS graduate with 5+ years cGMP pharmaceutical operations experience. 

·         Understanding of basic computer skills.