Manufacturing Associate-2Nd Shift

• 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 a science/technical discipline

Manufacturing Associate II

Basic Qualifications:

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

Preferred Qualifications:

• 1+ year experience in a sterile pharmaceutical operation

• Associates degree or higher in a science/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 a science/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

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