This is a 2nd shift position. The hours for the position are 2:00pm to 12:30am Monday, Tuesday, Wednesday and Friday.

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.

Responsibilities

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.

Qualifications

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

Sr Manufacturing Associate

Basic Qualifications:

High school diploma or equivalent.

4-5 years of experience in a pharmaceutical operation.

Preferred Qualifications:

Associate degree or higher in science/technical discipline

4-5 years of experience in a sterile pharmaceutical operation.

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. Ab

Alkermes, Inc.

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