Pharmaceutical Operator II

CatalentGreenville, NC
415d

About The Position

The Pharmaceutical Operator II at Catalent Pharma Solutions plays a crucial role in supporting formulation and process development activities within the Development, Pre-Commercial, and Scale-Up Manufacturing Areas. This position involves assisting in the development and optimization of formulations and processes, ensuring compliance with GMP guidelines, and maintaining accurate documentation. The role requires a proactive approach to inventory management and the ability to perform various tasks related to calibration, analysis, and facility maintenance.

Requirements

  • Bachelor's degree in Chemistry, Engineering or related science; OR an Associate's degree in Applied Science with four years of equivalent pharmaceutical industry experience; OR a high school diploma or equivalent with six years of equivalent pharmaceutical industry experience.
  • Ability to lift in excess of 50 lbs unassisted.
  • Ability to stand for extended periods of time and perform physical tasks such as bending, squatting, reaching, pushing, and climbing.

Nice To Haves

  • Experience in a pharmaceutical manufacturing environment.
  • Familiarity with GMP guidelines and documentation practices.

Responsibilities

  • Assist with the writing of SOP's, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed.
  • Ensure that all work is accurate, precise, properly documented, and performed within GMP guidelines.
  • Support and assist in the qualification of facility and equipment with some supervision.
  • Help ensure that an adequate inventory of raw materials is maintained at all times, working with inventory control personnel.
  • Maintain competence and training documentation for relevant equipment and processes.
  • Perform additional assigned tasks including calibration, analysis, cleaning, facility maintenance, raw material inventory, and warehouse operations.
  • Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities in the development group.
  • Assist development staff in activities related to the development and optimization of suitable formulations and processes, stability, and GMP batches.

Benefits

  • Competitive medical benefits and 401K
  • 152 hours of PTO + 8 Paid Holidays
  • Dynamic, fast-paced work environment
  • Opportunity to work on Continuous Improvement Processes
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