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Manufacturing Associate I-2nd Shift-Bulk

Alkermes
Wilmington, OH Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/22/2025

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 the Manager.
  • Shift coverage and weekend work may be required.

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 gown in an aseptic manner for clean room operations.
  • Physical Requirements :

  • Occasional periods of repetitive motion.
  • Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
  • Ability to operate all types of production equipment
  • Ability to read, understand, and follow company SOP guidelines.
  • Ability to lift / move up to 50 lbs. Ability to team lift up to 100 lbs.
  • Ability to stand in steel-toed shoes for a minimum of 7 hrs.
  • 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.
  • Associate degree or higher in a science / technical discipline
  • Manufacturing Associate II

    Basic Qualifications :

  • High School Diploma or equivalent
  • 1-3 years of pharmaceutical manufacturing or equivalent experience.
  • Preferred Qualifications :

  • 1 year experience in a sterile pharmaceutical operation
  • Associate degree or higher in a science / technical discipline
  • Manufacturing Associate III

    Required Education and Experience

  • High School diploma or equivalent.
  • 4-5 years of pharmaceutical manufacturing or equivalent experience
  • Preferred Education and Experience

  • 2-3 years experience in a sterile pharmaceutical operation
  • Associate degree or higher in a science / technical discipline
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