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:

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

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