Manufacturing Associate

2 openings available: 1st shift and 2nd shift

• M-Th 3pm-1:30am 4x10 2nd Shift (pay rate: $22/hour)
• M-F 7-330pm 1st Shift (pay rate: $20/hour)

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.

• 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.

• 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.

• Integrity/Ethics
• 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

• High School diploma or equivalent.
• Preferred Requirements:
• 0-1 year of experience in a sterile pharmaceutical operation.
• Associates degree or higher in science/technical discipline.