Alkermes - Manufacturing Associate I

MANUFACTURING ASSOCIATE I GENERAL DESCRIPTION: Entry level position for persons to manufacture commercial scale batches.

KEY DUTIES:• Production, filling and inspection of pharmaceutical formulations.• Assist with facility cleaning and operational maintenance.• Assist with facility and process validations as required.• Perform aseptic production operations and validations.• Assist with environmental and water system monitoring as required.• Assist with clean room sanitization as required.• Assist with RCRA and safety inspections as required.• Document all work as required by CGMPs on a timely basis.• Read and follow all Company SOPs and guidelines.• Abide by all safety requirements as defined by the company.• Other tasks as assigned by team leader.SKILLS/ABILITIES:• Basic knowledge of the Scientific Method• Basic math skills, including simple algebra• Basic knowledge of and adherence to current GMP.• Basic knowledge of chemistry and biology.• Basic knowledge of steam/dry heat sterilization theories.• Basic knowledge of HAZCOM, RCRA and other Safety requirements.• Basic level of mechanical aptitude.• Good documentation skills.• Ability to lift / move 40 lbs. overhead.• Ability to learn how to operate all types of production equipment (I.e. Autoclave, Honeywell DCS panels, CIP system, Dry Heat Oven, Process Waste system, etc.).• Ability to read, understand and accurately follow company SOPs and guidelines.PERSONAL ATTRIBUTES:• Detail oriented.• Willing to learn new tasks, skills.• Works well in a team environment.• Responds quickly to assignments.• Readily adapts to changing job duties.• Positive attitude.• Displays understanding of and promotes company and customer objectives.EDUCATION AND EXPERIENCE:• High School diploma or equivalent.• 0-1 years experience in a sterile pharmaceutical operation.