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Manufacturing Associate-4a-12p

4 months ago

Wilmington, Delaware, United States Alkermes, Inc. Full time

*This position is located in Wilmington, Ohio

Summary:

Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation

Job Description:

  • Read and follow detailed written SOPs / Procedures
  • Document all work as required by cGMPs on a timely basis
  • Executes tasks as directed with close attention to detail
  • Monitors Process with close attention to detail
  • Abide by all safety requirements as defined by the company
  • Can work independently without constant supervision
  • Follows Alkermes internal policies
  • Works well in a team environment
  • Perform facility / equipment cleaning and set-up
  • Assist with Development activities and Validation as required
  • Other tasks as assigned by Manager
  • Shift coverage and weekend work may be required

Minimum Education & Experience Requirements:

Manufacturing Associate I

Basic Requirements

  • High School diploma or equivalent.

Preferred Requirements

  • 0-1 year experience in a sterile pharmaceutical operation preferred.
  • Associates degree or higher in ascience/technical discipline

Manufacturing Associate II

Basic Qualifications:

  • High School Diploma or equivalent
  • 1-3 year of pharmaceutical manufacturingor equivalent experience.

Preferred Qualifications:

  • 1+ year experience in a sterile pharmaceutical operation
  • Associates degree or higher in ascience/technical discipline

Manufacturing Associate III

Required Education and Experience

  • High School diploma or equivalent.
  • 4-5 years' experience in pharmaceutical Manufacturing

Preferred Education and Experience

  • 2-3 years' experience in a sterile pharmaceutical operation
  • Associates degree or higher in ascience/technical discipline

Knowledge/Skills Needed:

  • General math skills, including simple algebra
  • General knowledge of and adherence to Current Good Manufacturing Practices
  • General knowledge of 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 word processing/spreadsheet skills
  • Good written communication
  • Excellent documentation skills
  • Ability to lift / move 50lbs. overhead. Ability to team lift 100 lbs
  • Ability to operate all types of production equipment (i.e. Rockwell HMI, CIP system, etc.)
  • Ability to gown for clean room operations
  • Ability to read, understand, and accurately follow company SOPs and guidelines

#LI-AH1

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