Alkermes-posted 3 months ago
Entry Level
Wilmington, OH
Chemical Manufacturing

This position is based in Wilmington, OH. Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System.

  • Read and follow detailed written SOP's/MPR's/Procedures.
  • Document all work as required by cGMP's on a timely basis.
  • Execute tasks as directed with close attention to detail.
  • Monitors process with close attention to detail.
  • Follows Alkermes internal policies.
  • Abide by all safety requirements as defined by the company.
  • Perform Aseptic Gowning and maintaining gowning qualification.
  • Perform clean room sanitizations.
  • Perform equipment prep/assembly/setup.
  • Operate equipment used in filling of microspheres/suspensions/liquid products.
  • Assist with Development and Validation activities as required.
  • Other tasks as assigned by Manager.
  • Shift coverage and weekend work may be required.
  • High School diploma or equivalent.
  • General knowledge of aseptic fundamentals.
  • General math skills, including using metric weight system.
  • General Knowledge and Adherence to Current Good Manufacturing Practices.
  • General Knowledge HAZCOM RCRA, and other safety requirements.
  • Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
  • General computer skills.
  • Excellent documentation skills.
  • 0-1 year of experience in a sterile pharmaceutical operation.
  • Associates degree or higher in science/technical discipline.
  • 1-3 years of pharmaceutical manufacturing or equivalent experiences.
  • 1+ year in a sterile pharmaceutical operation.
  • 4-5 years of pharmaceutical manufacturing or equivalent experiences.
  • 2-3 years of experience in a sterile pharmaceutical operation.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service