Manufacturing Associate I-2nd Shift-Bulk
: Job Details :

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 documentationof 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 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.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.Minimum Education & Experience Requirements:Manufacturing Associate IBasic 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 disciplineManufacturing Associate IIBasic 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 disciplineManufacturing Associate IIIRequired Education and Experience* High School diploma or equivalent.* 4-5 years of pharmaceutical manufacturing or equivalent experiencePreferred Education and Experience* 2-3 years experience in a sterile pharmaceutical operation* Associate degree or higher in a science/technical discipline#LI-AH1