Manufacturing Associate-Filling 3rd Shift

This position is based in Wilmington, OH Hours: Sunday to Thursday 2300 to 0730 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 Requirements: MANUFACTURING ASSOCIATE 1 Basic Requirements: - 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. MANUFACTURING ASSOCIATE 2 Basic Qualifications: - High School diploma or equivalent. - 1-3 years of pharmaceutical manufacturing or equivalent experience. - Preferred Qualifications: - 1+ year in a sterile pharmaceutical operation. - Associates degree or higher in science/technical discipline. MANUFACTURING ASSOCIATE 3 Basic Qualifications: - High school diploma or equivalent. - 4-5 years of pharmaceutical manufacturing or equivalent experience. - Preferred Qualifications: - 2-3 years of experience in a sterile pharmaceutical operation. - Associates degree or higher in science/technical discipline Physical Requirements: - Occasional periods of repetitive motion. - Aseptic gowning must be maintained, including an annual requalification. - Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. - Ability to operate all types of production equipment (i.e., Rockwell HMI, Autoclaves, etc.) - Ability to read, understand, and accurately follow company SOP’s and guidelines. - Ability to lift/move up to 50 lbs. overhead. Ability to team lift up to 100 lbs. - Ability to stand in steel-toed shoes for a minimum of 7 hrs. #LI-AH1 ### About the Company **Why join Team Alkermes?** Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.…