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Manufacturing Associate-4a-12p

4 months ago

Wilmington, United States Alkermes Full time

*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 (. Rockwell HMI, CIP system, Ability to gown for clean room operations Ability to read, understand, and accurately follow company SOPs and guidelines

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