Manufacturing Associate I-2nd Shift-Bulk at Alkermes, Inc.

Posted in Facilities 7 days ago.

Type: Full Time
Location: Wilmington, Ohio





Job Description:

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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