Job Description

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations and to supervise individuals performing these actions.
• Participate in all Quality Investigations as required. Be able to provide written support as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOPs and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

Education and / or Experience:

• High School Diploma or GED Equivalent with 10-15 years related experience in cGMP production operation activities and limited supervisor experience or bachelor's degree in physical sciences or pharmaceutical life-science related field of study.
• Familiarity with working and supervising operators in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Able to work with minimal supervision.
• Maintain personal hygiene habits consistent with working in a cGMP environment.
• Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.

Must have Valid work permit.

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