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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