Manufacturing Associate-2nd Shift

This is a 2nd shift position. The hours for the position are 2:00pm to 12:30am Monday, Tuesday, Wednesday and Friday. 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. ### Responsibilities Responsibilities - 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 the Manager. - Shift coverage and weekend work may be required. 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 gown in an aseptic manner for clean room operations. ### Qualifications 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. - Associate degree or higher in a science/technical discipline Manufacturing Associate II Basic Qualifications: - High School Diploma or equivalent - 1-3 years of pharmaceutical manufacturing or equivalent experience. Preferred Qualifications: - 1+ year experience in a sterile pharmaceutical operation - Associate degree or higher in a science/technical discipline Manufacturing Associate III Required Education and Experience - High School diploma or equivalent. - 4-5 years of pharmaceutical manufacturing or equivalent experience Preferred Education and Experience - 2-3 years experience in a sterile pharmaceutical operation - Associate degree or higher in a science/technical discipline Sr Manufacturing Associate Basic Qualifications: - High school diploma or equivalent. - 4-5 years of experience in a pharmaceutical operation. Preferred Qualifications: - Associate degree or higher in science/technical discipline - 4-5 years of experience in a sterile pharmaceutical operation. Physical Requirements: - Occasional periods of repetitive motion. - Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. - Ability to operate all types of production equipment - Ability to read, understand, and follow company SOP guidelines. - Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs. - Ability to stand in steel-toed shoes for a minimum of 7 hrs. ### 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.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio…