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
• 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

LI-AH1

Last updated : 2024-04-23