Job Purpose
Responsible for the execution of all aspects of solid-dosage manufacturing
which includes, but is not limited to, the dispensing, granulation, sifting,
milling, drying, encapsulation, coating, compression, and 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:
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Assist Production Management with all scheduled and requested activities
in an efficient and smooth operation.
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Ensure all scheduled commercial and non-commercial manufacturing
activities are completed on time.
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Become proficient in the setup, operation, and cleaning of all cGMP
equipment used during production operations.
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Participate in all Quality Investigations as required.
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Adhere to all approved Standard Operating Procedures, Batch Records, and
Safety Procedures as written when performing all daily activities.
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Ensure the cGMP area is cleaned and maintained following all SOP’s and
good housekeeping practices.
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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:
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Familiarity with working in a regulated pharmaceutical solid dosage
facility.
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Ability to read and write documents written in English.
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Excellent written communication skills.
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Familiarity with various cGMP solid dosage Pharmaceutical manufacturing
equipment. Able to setup, operate clean, and troubleshoot the solid dosage
Pharmaceutical manufacturing equipment being used.
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Able to work with minimal supervision.
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Able to stand on feet throughout an eight-hour work day.
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Able to lift up to 30 Ibs (14 Kgs) without assistance.
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Maintain personal hygiene habits consistent with working in a cGMP
environment
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Be capable of wearing all required PPE; including partial and full
facepieces based on OSHA guidelines.
Education :
High School Diploma or GED Equivalent.
Bachelor’s degree in Physical Sciences or Pharmaceutical life science
related field of study.