Job Description

Job Purpose

Responsible for the execution of all aspects of solid-dosage manufacturing which includes but is not limited to packout of finished goods bottles. In addition, responsible for all cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

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

• Assist Packaging Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial packing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during packaging operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the primary and secondary packaging area is cleaned and maintained following all SOP’s and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Familiarity with various cGMP solid dosage pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour workday.
• Able to lift up to 30 Ibs (14 Kgs) without assistance.
• 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.

Education and/or Experience:

Education: High School Diploma or GED Equivalent, bachelor’s degree in physical sciences or pharmaceutical life science related field of study.

Years of related experience and/or training

3-10 years related experience in cGMP production/packing operation activities.

Job Tags

Similar Jobs