Manufacturing Associate

This position is based in Wilmington, OH

Hours: Monday to Thursday  3:00 PM to 1:30 AM

Summary:

Perform all necessary operation activities related to filling of microsphere/suspension/liquid products.  These activities include but are not limited to the following:  Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s with thorough documentation of operations according to cGMP.  Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed.  Maintain individual training proficiency through individual Learning Management System. 

Responsibilities

Responsibilities:

• Read and follow detailed written SOP’s/MPR’s/Procedures.
• Document all work as required by cGMP’s on a timely basis.
• Execute tasks as directed with close attention to detail.
• Monitors process with close attention to detail.
• Follows Alkermes internal policies.
• Abide by all safety requirements as defined by the company.
• Perform Aseptic Gowning and maintaining gowning qualification. (this includes wearing of hood, coverall, boots, mask, goggles, gloves)
• Perform clean room sanitizations.
• Perform equipment prep/assembly/setup.
• Operate equipment used in filling of microspheres/suspensions/liquid products.
• Assist with Development and Validation activities as required.
• Other tasks as assigned by Manager.
• Shift coverage and weekend work may be required. 

Skills/Abilities:

• General knowledge of aseptic fundamentals.
• General math skills, including using metric weight system.
• General Knowledge and Adherence to Current Good Manufacturing Practices.
• General Knowledge 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 skills.
• Excellent documentation skills.

Personal Attributes:

• Positive Attitude 
• Integrity/Ethics
• Adaptability/Flexibility
• Dependability
• Detailed Oriented
• Self-Motivated
• Responds Quickly to Assignments
• Works Well in a Team Environment.
• Adapts Well to Changing job duties.
• Takes Ownership and is Willing to Learn new tasks/skills

Qualifications

Minimum Education & Experience Qualifications:

Basic Qualifications